Ambulation Following Lower Extremity Skin Grafts By: Aubrey Rimer Doctoral Candidate University of New Mexico School of Medicine Division of Physical Therapy Class of 2015 Advisor: Tiffany Pelletier PT, DPT Approved(by(the(Division(of(Physical(Therapy,(School(of(Medicine,( University(of(New(Mexico(in(partial(fulfillment(of(the(requirements(for( the(degree(of(Doctor(of(Physical(Therapy.( Table of Contents ABSTRACT ______________________________________________________________________ 3 SECTION 1: BACKGROUND AND PURPOSE ___________________________________________ 4 SECTION 2: CASE DESCRIPTION _________________________________________________ 5 - 13 INTRODUCTION 5 EXAMINATION 6 PATIENT HISTORY 6 SYSTEMS REVIEW 7 TESTS AND MEASURES 8 EVALUATION 9 DIAGNOSIS 9 ASSESSMENT 9 PROBLEM LIST 10 PLAN OF CARE 10 PROGNOSIS & GOALS 10 INTERVENTIONS 11 OUTCOMES 12 SECTION 3: EVIDENCE BASED ANALYSIS _________________________________________ 13 - 14 METHODOLOGIES OF SEARCH 13 DISCUSSION 14 CONCLUSION 15 REFERENCES ____________________________________________________________________ 16 TABLES & FIGURES __________________________________________________________________ TABLE 1: TESTS AND MEASURES 8 TABLE 2: DIAGNOSIS, ICD-9 CODES, AND PHYSICAL THERAPY DIAGNOSIS 9 TABLE 3: PHYSICAL THERAPY PROBLEM LIST 10 TABLE 4: LITERATURE RESULTS 18 TABLE 5: LITERATURE INCLUSION / EXCLUSION CRITERIA 20 FIGURE 1: ARTICLES INCLUDED AND EXCLUDED FOR ANALYSIS 17 APPENDIX A: EVIDENCE APPRAISAL _____________________________________________ 21 - 63 ( ! ( 2! ABSTRACT BACKGROUND / PURPOSE: The standard protocol for ambulating patients following split-thickness skin grafts to the lower extremity is an initial several days of immobilization. Research over the past decades supports a trend towards earlier ambulation, however burn clinics nation wide have been hesitant to implement such protocols.1 The purpose of this literature review was to answer to the following PICO question: In adults with lower extremity split thickness skin grafts secondary to full-thickness burns, is early ambulation better than late ambulation in regards to preserving functional mobility while ensuring graft healing? CASE DESCRIPTION: The patient was a 22-year-old male with no significant past medical history, admitted for partial and full thickness flame burns to the posterior aspect of the left lower extremity covering approximately 4% of his total body surface area. METHODS: An electronic search of the literature was performed with a critical appraisal of eight articles. Chosen studies compared early ambulation, defined as ≤ 3 days of bed rest, to late ambulation, defined as ≥ 4 days of bed rest, on graft healing.2 OUTCOMES: There was a consensus in the literature supporting immediate ambulation of patients with isolated lower extremity burns. No studies of any patient population showed that early ambulation compromises graft take. CONCLUSION: Immediate ambulation is a safe intervention for patients who were previously ambulatory, are medically and psychologically stable, with wounds <300cm2 that are not on the plantar surface of the foot. Ambulation is safe to begin once the patient recovers from anesthetic (4 to 48 hours post-op) with compression wrapping and splinting of any joints the graft crosses. ! 3! SECTION 1: BACKGROUND AND PURPOSE This case study involved a 22-year-old male admitted to the burn clinic for partial and full thickness flame burns to the posterior aspect of the left lower extremity covering approximately four percent of his total body surface area. The patient had no significant prior medical history, was generally healthy, and worked delivering medical equipment. Two million burn accidents occur each year in the US, with 500,000 patients receiving medical treatment, 40,000 requiring hospitalizations, and 4,000 resulting in death.3 Fire and flame account for 46% of all burns, and roughly 70% of burn victims are male.3 In addition to burns, other causes of full thickness integumentary impairments requiring skin grafting include lesions, venous stasis ulcers, diabetic ulcers, and lacerations. The most common surgical interventions for these injuries are skin grafts or flaps.4 Flaps are a unit of skin, underlying tissue, and blood supply transferred from a donor site to a recipient site. They are more complex, were not an indicated intervention for this case study, and are not included within the scope of this research. Skin grafts consist of the epidermis and varying amounts of dermis depending on whether they are splitthickness or full thickness grafts. Grafts are not vascularized and require neovascularization for survival. This process takes between four to six days.5 During this period of revascularization there is concern over increasing the risk of graft failure by either floating the graft off of the wound bed with edema or hematoma, or with shearing forces. Consequently, it has been the common practice to restrict skin graft patients to post-operative bed rest for an average of five days.1,5 ! 4! Studies that investigate ambulation protocols following skin grafting dating back to the 1970s have supported early ambulation; however burn clinics nation wide have been hesitant to implement such protocols, due to continued fear of graft failure from hematoma, shearing, or lack of graft adherence, as well as the only recent development of practice guidelines.1,2,6 The purpose of this investigation into the literature was to answer to the following PICO question: In adults with lower extremity split thickness skin grafts secondary to full-thickness burns, is early ambulation better than late ambulation in regards to preserving functional mobility while ensuring graft healing? SECTION 2: CASE DESCRIPTION INTRODUCTION The case study involved a 22-year-old male with no significant past medical history, admitted to the hospital burn clinic for partial and full thickness flame burns to the posterior aspect of the left lower extremity covering approximately 4% of his total body surface area. The patient sustained the burn when he attempted to move a pallet into a bonfire, caught his leg on the pallet, tripped, and the burning pallet fell onto the posterior side of his left lower leg. The patient sought early medical attention from his primary care physician, receiving initial wound care. At a follow-up appointment with his primary care physician the wound was evaluated and it was determined further medical attention was required due to the depth of the burns. That same day the patient was evaluated by a physician at the hospital and scheduled for debridement and homograft surgery in five days. The day after homograft placement he was evaluated by physical therapy. Three days later the patient was taken to the operating room for debridement and autografting. Three days after autografting, on postoperative day three, the bandages were removed and an initial observation of the graft was performed along with an order to begin physical therapy. That same day the patient was discharged from the hospital ! 5! home with family support and follow-up scheduled in the outpatient burn clinic. His total hospital length of stay was 7 days. EXAMINATION: HISTORY, SYSTEMS REVIEW, AND TESTS & MEASUREMENTS HISTORY Initial Physician Visit: Mid-October followed by homograft surgery 5 days later. PT EVALUATION: 1 day status post homograft surgery CHIEF COMPLAINT: Partial and full thickness flame burns to posterior aspect of left lower leg (540 square centimeters, roughly 4% total body surface area), status post excision and homograft placement. He spent the night on bedrest in the PACU (post-anesthesia care unit) awaiting an open recovery room. HISTORY OF PRESENT ILLNESS: The patient was a 22-year-old male who reported attending a bonfire approximately two weeks ago at which he moved a large pallet into the fire, tripped, and the pallet fell onto the posterior aspect of his left leg. He was wearing jeans at the time and was unsure how long the pallet remained on his leg. He sought early medical attention from his primary care provider; receiving local wound care with Silvadene and petroleum gauze dressings. The patient was later reassessed by his primary care provider who felt that the wounds were significant enough to require referral to the hospital, where the patient was assessed and scheduled for homografting The patient complained of constant burning pain in the left lower extremity, which was relieved by pain medication, and increased by movement, rubbing of clothing, and showering. ! 6! His current complaint was only of some tightness of the left knee. Split-thickness skin graft placement was scheduled for the following day with a tentative discharge in 4 days, with a total hospital length of stay of 7 days. PATIENT MEDICAL HISTORY: no significant past medical history SURGICAL HISTORY: tonsils and adenoids removed as a child MEDICATIONS: none OCCUPATION: Pt was employed delivering durable medical equipment. LIVING ENVIRONMENT: Pt lived in a condo with his mother and father. There were 7 stairs up to enter the front door of the condo, no stairs inside. Mother was available 24/7 to provide assistance as needed. PRIOR LEVEL OF FUNCTION: Pt was independent with all mobility, ADLs, and driving. FAMILY HISTORY: Denied family history of bleeding disorders or reactions to anesthesia. Both parents were living. SOCIAL HISTORY: Denied tobacco and illicit drugs, occasional alcohol use PATIENT VALUES / GOALS: Pt hoped to return to work as soon as possible. He was unconcerned about potential scarring, stating, “I’ll look tough”. SYSTEMS REVIEW: VITAL SIGNS: Blood Pressure 126/73, Pulse Rate 72, Temperature 36.8, Respirations 18 bpm, O2Sat 96% on room air, Height 180 centimeters, Weight 97 kilograms, BMI of 30. GENERAL: Young male with no apparent distress upon examination HEENT: Head: Normocephalic, atraumatic. Eyes: Pupils were equal, round and reactive to light. Extraocular muscles were intact. Sclerae were anicteric. Nose: without epistaxis. Throat: no thyromegaly. Trachea was midline. Range of motion was full. CARDIOVASCULAR: Regular rate and rhythm. No murmurs, rubs or gallops. PULMONARY: Clear to auscultation bilaterally. No wheezes, rales or rhonchi. ! 7! GASTROINTESTINAL: Abdomen was soft, nontender, nondistended, positive bowel sounds. No organomegaly or splenomegaly noted. SKIN: No rashes or other lesions noted. Approximately 4% total body surface area burn to his posterior leg, including both full thickness and partial thickness areas. Full thickness is approximately 200 square centimeters at time of evaluation. NEUROLOGIC: Strength and sensation were grossly intact. Alert and appropriate for his age. PSYCHIATRIC: No obvious signs of anxiety or depression. TESTS AND MEASURES: Table 1: Tests and Measures Tests and MD Eval Measures Orientation Alert & Orientated x4 Intact command following, safety/judgment, problem solving Pain Left posterior lower leg: burning Increases with movement and showering, decreases with pain meds Wound / Burns: 4% total Graft body surface area Assessment Full thickness: 200 cm2 ROM Strength Sensation Proprioception ! PT Eval s/p allograft Alert & Orientated x4 Intact command following, safety/judgment, problem solving PT Eval s/p autograft POD 3 Alert & Orientated x4 Intact command following, safety/judgment, problem solving PA Outpt Burn Clinic Alert & Oriented x4 Left knee: tightness Left thigh donor site: stinging Some itching to left calf, no pain Excision and homograft (10/28) Unable to visually assess. Per medical team graft does not cross ankle/knee joints and is 540 cm2 in size Debridement and STSG (10/30) Assessed at dressing take down. Meshed, no signs of infection, no drainage, intact wound margins, clear in color, small hematoma present. Grossly WFL Graft: Intact, well healed, no open wounds, no signs of infection Donor Site: well healed, slight pink discoloration WFL, no problems with ambulation Grossly WFL Grossly intact Grossly intact Grossly 4-5/5 Intact fine touch and localization of touch Intact bilateral toes Grossly 4-5/5 Not tested Not tested 8! Tests and Measures Coordination Balance: Sitting Standing Bed Mobility Transfers: Sit to Stand / Stand to Sit Ambulation Distance Level of assistance Assistive Device Gait Stairs MD Eval PT Eval s/p allograft Intact bilaterally Sitting: Good Standing: Fair (Contact guard assist with initial standing, improved to supervision) Modified Independent PT Eval s/p autograft POD 3 Not tested Sitting: Good Standing: Good Contact Guard / Supervision 100 ft Standby Assistance No assistive device Gait: initially slow with decreased step length on R, normalized with cuing and practice Independent / Independent 150 feet x2 Standby Assistance No assistive device Gait: slight decrease of left ankle ROM secondary to dressings. Initial slight decrease of knee ROM, which normalized with cueing and stretching. Not tested Not tested PA Outpt Burn Clinic Independent Independent / Independent EVALUATION: DIAGNOSIS: Table 2: Diagnosis, ICD-9 Codes, and physical therapy diagnosis Diagnosis ICD-9 Codes Physical Therapy Diagnosis Practice Pattern 7D: Impaired Integumentary Partial and full thickness flame 945.3 Integrity Associated With Full-Thickness Skin burns to the left lower extremity Involvement and Scar Formation NARRATIVE ASSESSMENT The patient was a 22-year-old male status post an initial excision and homograft placement, followed by split-thickness autograft placement secondary to partial and full thickness flame burns to the posterior aspect of the left lower extremity. Burns covered approximately 4% of total body surface area. ! 9! The patient was otherwise healthy with no significant prior medical history. The patient presented with left lower extremity graft, minimally limited left ankle range of motion during ambulation, decreased endurance, and an increased risk of hypertrophic scarring and possible contracture of left ankle and knee due to age and location and depth of burns. The patient was previously independent with all mobility and activities of daily living, worked delivering durable medical equipment, and lived with his parents in a condo with seven steps to enter. Skilled physical therapy was recommended to minimize risk of scar contracture formation and maximize functional outcomes. CLINICAL JUDGMENTS AND PROBLEM LIST Table 3: Physical therapy problem list Wounds Range of Motion Pain Physical Activity Gait Work Recreation Impairments 1. Split thickness autograft covering 4% total body surface area (540 cm2) on left posterior leg 2. Donor site on left anterior thigh 3. Minimally limited left ankle ROM 4. Stinging at donor site, itching at graft site Functional Limitations 5. Limited dependent positioning of left lower extremity (sitting, standing, ambulating) 6. Decreased gait speed 7. Decreased left toe clearance during ambulation Participation Restrictions 8. Unable to work delivering durable medical equipment 9. Unable to play flag football PLAN OF CARE Physical therapy sessions 2-3x per week until goals were met or patient was discharged from hospital. Physical therapy anticipated interventions included transfer training, gait training, therapeutic exercises, therapeutic activities, balance training, self-care education, caregiver training, safety education, pain management, and joint protection. ! 10! SHORT TERM GOALS (2 weeks): 1. Patient will demonstrate ROM within normal limits by goniometric measurement of left knee and ankle. 2. Patient will Ambulate a minimum of 300 feet over variable surfaces with equal gait pattern independently and without assistive device. 3. Patient will ascend/descend 7 stairs reciprocally with safe technique and 1 rail. 4. Patient will independently don/doff ace compression wrapping from left toes to thigh in figure-8 pattern. 5. Patient will demonstrate/verbalize precautions and positioning to maximize graft healing. LONG TERM GOALS (1 month): 6. Patient will return to work delivering durable medical equipment. 7. Patient will verbalize and demonstrate long term skin care including sun protection, protection against shearing forces and correct use of compression garments. PROGNOSIS: The rehab prognosis for this patient to meet the above goals was excellent. The patient’s graft was well adhered, he had minimal pain, was in good health with no comorbidities, and had a supportive mother who was available 24/7 to assist as needed. Both the patient and his mother recalled positioning, ROM, wound care, compression wrapping, and long-term skin care instructions. He was scheduled a followup appointment in the Outpatient Burn Clinic in two weeks. INTERVENTIONS The patient was seen twice by physical therapy during his acute care hospital stay: once for an initial evaluation following allograft surgery, and once for a re-evaluation following autograft surgery (See Table 1: Tests and Measures, for details). The patient was originally evaluated by physical therapy following allograft placement. During this visit the left leg was figure-of-8 wrapped to the knee, history was taken, and the patient’s bed mobility, transfers, ! 11! and ambulation were assessed. He was not seen by physical therapy again until new orders were placed following his autograft surgery on post-operative day three. After reviewing the evidence, this patient met the criteria for immediate ambulation following recovery from anesthesia, and would have been a good candidate for such an intervention. This would have allowed for more physical therapy sessions during his acute care stay. However, the patient was not seen by physical therapy until post-op day three when the surgical dressings were removed by the Physician Assistant for the initial viewing of his graft. Assessment of the graft showed no signs of infection, no drainage, intact wound margins, the graft was clear in color, and there was a small hematoma present. The graft did not cross the ankle or knee joints. Due to the high quality of graft adherence, discharge orders were placed by the surgeon for that same afternoon. Nursing completed wound cleaning, bandage placement, and returned the patient to his room. The patient was then seen by PT for re-evaluation of mobility, education on compression wrapping, positioning, graft care, the PT plan of care, family training, and instruction in a home exercise program including range of motion for the ankle and knee. The left lower extremity was wrapped from toes to thigh, just below the donor site, with elastic bandages in figure-of-8 pattern. The donor site was left bare for the remainder of its healing, however the patient was instructed on how to compression wrap from toes to above the waist for donor site comfort as needed. Both the patient and his mother were instructed on the compression wrapping technique and when to use it. The patient was educated on positioning of the limb to limit dependent positioning, and to promote elevation to reduce the risk of edema. Protection against shearing forces was addressed. The patient’s bed mobility, transfers, and ambulation were assessed (see Table 1: Tests and Measures, for details). Gait training and ankle and knee range of motion exercises were performed to improve symmetry of stride length, increase toe push-off and heel strike on the left, increase ! 12! endurance, and prevent contracture due to scar formation to normalize gait pattern and return to prior level of function. The patient was discharged home with a scheduled follow-up appointment in Outpatient Burn Clinic in two weeks. OUTCOMES The patient was seen for two physical therapy visits before being discharged from the hospital. On the day of discharge he was independent with bed mobility, transfers, and ambulation of 150 feet. Goals met included the ability to don and doff compression wrapping independently, and verbalize positioning, longterm skin care, and protection against shearing. The patient was making progress towards the remaining goals. Stairs were not assessed at time of discharge. The patient was scheduled for follow-up with physical therapy in the Outpatient Burn Clinic. SECTION 3: EVIDENCE BASED ANALYSIS METHODOLOGIES OF SEARCH: An electronic search was conducted using Pubmed, CINAHL, Cochrane, and Web of Knowledge databases for research concerning ambulation protocols following lower extremity skin grafting secondary to full thickness burns. Search terms included ‘ambulation’, ‘mobilization’, and ‘lower extremity skin graft’. Search methods are detailed in Figure 1. The search was limited to articles written within the last twenty years, in English, with adult human subjects. Articles were excluded if they were case studies, involved flap procedures, included wound vac or unna boot interventions, or contained complex trauma patients. The search identified an initial 136 articles, after exclusions, eight appropriate articles were appraised using forms adopted from the Guide to Evidence-Based Physical Therapy Practice7 (See Appendix A). ! 13! DISCUSSION The objective of this literature review was to answer the following PICO question: In adults with lower extremity split thickness skin grafts secondary to full-thickness burns, is early ambulation better than later ambulation in regards to preserving functional mobility while ensuring graft healing? The articles reviewed compared early ambulation protocols to the traditional late ambulation protocols and their effects on graft healing. A consensus was revealed in the literature supporting immediate ambulation following lower extremity split-thickness skin grafting, noting that early ambulation neither improves or jeopardizes graft take if external compression is applied1,2,4,5,6,8,9). Despite evidence advocating for early ambulation following split skin graft surgeries, studies reviewing plastic surgery departments nationwide suggests it is not routinely practiced1. The burn center followed a traditional ambulation protocol for the majority of its patients. Many of these patients are complex, with multiple comorbidities, systemic diseases, and were the types of patients excluded from studies on graft healing. Wallenberg included subjects with questionable peripheral arterial circulation as well as diabetics, and concluded that graft failure was related to systemic diseases rather than ambulation protocols9. More research into this patient population is needed to determine if they too may benefit from early ambulation after grafting. There has been a general healthcare trend towards early ambulation of patients, primarily to prevent secondary complications from bed rest including deconditioning, pulmonary embolism, joint stiffness, and prolonged hospital stays. Secondary outcome measures in several studies included length of stay, deconditioning, ambulation distance, and pain. The majority of studies measuring length of stay found a significant reduction among early ambulatory groups1,2,8, one found no significant difference5. Deconditioning and pain were found to be reduced by early ambulation5,8. ! 14! All the studies reviewed included the use of compression wrapping prior to the dependent positioning of the lower extremity. The precise application and guidelines for compression wrapping are not well defined. Some studies defined their use of compression wrapping as two-layers of elastic bandages applied in a figure-of-eight pattern; however the details of this application are unclear and vary by clinical site. Further research into compression wrapping parameters is needed. Several of the studies allow for bathroom privileges during bed rest for the late ambulation groups2,5,8. Distance to the restroom, whether the grafts were compression wrapped, time spent with the graft in dependent positioning, and whether the subjects ambulated independently, with assistance, or with an assistive device is unknown. The guidelines for patients on bed rest with bathroom privileges is an area of needed clarification. This case study was a young adult with no comorbidities, in overall good health, with a limited lower extremity skin graft. He had orders of bed rest with bathroom privileges, however he was observed ambulating approximately 200 feet in the hall without the advised external compression wrapping on postoperative day three. Despite this dependent positioning and lack of compression at times, his graft successfully healed. During his hospital stay he expressed a desire to ambulate more frequently and sooner than he was permitted. A review of the literature supports further promotion of early ambulation protocols by physical therapists in burn clinics. CONCLUSION / BOTTOM LINE The purpose of this study was to answer the following PICO question: In adults with lower extremity split thickness skin grafts secondary to full-thickness burns, is early ambulation better than late ambulation in ! 15! regards to preserving functional mobility while ensuring graft healing? There is a consensus in the literature that there is no difference in graft healing between patients managed with early mobilization versus postoperative bed rest. Immediate ambulation is a safe intervention for patients who were previously ambulatory, are medically and psychologically stable, with wounds <300cm2 that are not located on the plantar surface of the foot2. Ambulation is safe to begin once the patient recovers from anesthetic (4 to 48 hours post-op) with compression wrapping and splinting of any joints the graft crosses. ! 16! REFERENCES 1. Burnsworth B, Krob MJ, Langer-Schnepp M. Immediate ambulation of patients with lower-extremity grafts. J Burn Care Rehabil. 1992; 13: 89-92. 2. Nedelec B, Serghiou MA, Niszczak J, McMahon M, Healey T. Practice guidelines for early ambulation of burn survivors after lower extremity grafts. J Burn Care Res. 2012; 33: 319-329. DOI: 10.1097/BCR.0b013e31823359d9 3. Chirieleison S. Rehabilitation following a burn injury. 06/27/2014. Powerpoint Presentation. 4. Southwell-Keely J, Vandervord J. Mobilisation versus bed rest after skin grafting pretibial lacerations: A meta-analysis. Plast Surg Int. 2012; 207452. doi: 10.1155/2012/207452. 5. Lorello DJ, Peck M, Albrecht M, Richey KJ, Pressman MA. Results of a prospective randomized controlled trial of early ambulation for patients with lower extremity autografts. J Burn Care & Research. 2014; 35, 5: 431-436. 6. Smith TO. When should patients begin ambulating following lower limb split skin graft surgery? A systematic review. Physiotherapy. 2006; 92: 135-145. 7. Jewell DV. Guide to Evidence-Based Physical Therapist Practice, 2nd Ed. Jones and Bartlett Learning, LLC; 2011. 8. Luczak B, Ha J, Gurfinkel R. Effect of early and late mobilisation on split skin graft outcome. Australas J of Dermatol. 2012; 53: 19-21. 9. Wallenberg L. Effect of early mobilization after skin grafting to lower limbs. Scand J Plast Reconstr Hand Surg. 1999; 33: 411-413. 10. Harvey I, Smith S, Patterson I. The use of quilted full thickness skin grafts in the lower limb: reliable results with early mobilization. J of Plastic, Reconstructive & Aesthetic Surgery. 2007; 62; 969-972. ! 17! 85' ! ''''''''''''''''''''''' 7' 20' ! 4' ! 136'Articles'!'Excluded'95' 41'Articles'!''Excluded'29 ! 2' ' >10!years!old,!low!level!of!evidence! ! 0' 15'Articles'' Removed!duplicates!! ! 27' 8' Title'Search' Searched!cited! references! ! 6' OReviewed! OAnalyzed! OCompared!to!PICO! ! 8'Total'Articles' Figure'I.'Articles!Included!and!Excluded!for!Analysis! ! ! ! ! ! ! ! Keyword'Search' MeSH'Database! Keyword'Search' ! Two!different!keyword! Different!keyword! One!keyword! ! combinations!&!0!limits! combinations!&!2!limits! combination! ! ! ! !Based!on!relevance!of!title!to!PICO!question! ! ! ! 20' 4' 9' ! ! !! ! !! ! ! Topic!not!closely!related,!unavailable!in!full!text!or!English,!! ! ! Keywords:!! Ambulation! Lower!Extremity! Skin!Graft! ! 18! ! Luczak et al (2012) Australia Lorello et al (2014) USA Harvey et al (2007) Australia Burnsworth et al (1992) USA Study & Origin Retrospective Review Prospective Randomized Controlled Trial Case Series Retrospective Case Series Design Table 4. Section 3: Literature Results # 1 10 5 8 ! Oxford Level of Evidence 4 4 1b 2b Purpose of Study Compare early ambulation protocol at Mercy Burn Clinic to 109 other burn centers Determine if using quilted full thickness skin grafts on the lower limbs allows for early ambulation without graft loss due to shearing or friction. Demonstrate that pts beginning ambulation within 24 hours of LE grafting will have no increased risk of graft failure than those immobilized until POD 5. Review guidelines for the mobilization of post Subjects n= 58 Burns Average TBSA grafted: 4.1% n=60 92 grafts for lesions (BCC, SCC, Melanoma) below the knee Mean age 82.8 years n= 32 Burns n=48 Outcome Measures Results Helped Answer PICO Question Yes Ambulation day (>30 ft) Average graft take 96.4% EAG vs survey: Ambulate >30’ 1.7 vs 7.2 days (p<0.001). D/C 6.9 vs 9.4 days (p<0.01). LOS: 10.2 vs 12.6 days (p<0.012) No LOS Post-op day discharge Graft take 5 pt (7 grafts) did not attend 2 week follow up. At 2nd week: 100% take = 89.4%, 70-99% take = 5.9%, 50% take = 1.2%, 40% take = 1.2%, 0% take = 2.4% Yes Yes No difference in graft loss. Significant differences in deconditioning: 0 vs 6 EAG reported less graft site pain (1.3/10 vs 3.14/10) EAG walked longer on POD 5: 23.4 vs 12.03 minutes. Significant difference in percentage of graft loss: EAG 1.0% vs SAG: 7.7% Post-op ambulation day Graft take Pain at graft and donor sites Post-op d/c LOS Graft take Infection 19! ! Evaluate evidence for early ambulation of LE burns s/p grafting split skin graft patients. 3a Nedelec et al (2012) Canada Practice Guideline 2 1b Determine when to begin ambulation in patients with LE STSG 6 Systematic Review Smith, TO (2006) UK 1a 4 1c Determine whether strict bed rest is required after splitthickness skin graft surgery to the lower extremities. Assess early mobilization vs bed rest on skin grafting Prospective Randomized Study Review MetaAnalysis Wallenberg L (1999) Sweden Southwell-Keely et al (2011) Australia 9 ! 17 articles total n=644 Post-op ambulation day Graft take, LOS Deconditioning Hematoma Hypergranulati on LOS n=725 n=145 Graft take by POD 14 Graft take Graft healing, Systemic corticosteroids, post-op mobility n=50 All types of skin defects (p=0.008), Post-op LOS: 3.92 vs 7.96 days (p=0.0001), Total LOS: 7.72 vs 13.57 days. Yes Yes Yes No difference in graft healing between groups. Corticosteroids negatively effect graft healing. Yes No significant difference in graft loss: 88% vs 91% (p=0.45), infection (p=0.22), hematoma (p~1), or hypergranulation (p=0.24). Support for EA only with compression, & immobilized joints if crossed by graft Studies began ambulation immediately to >1 week postop. Ambulation does not significantly affect graft take. Grafts healed in 80% of the EAG and 88% in the SAG. 3 arterial leg ulcers did not heal. 2 graft site infections did not heal. All trauma wounds healed. 20! ! # Burnsworth et al (1992) Study ! Table 5: Literature Inclusion / Exclusion Criteria 1 Inclusion Criteria Patients from Mercy Hospital Burn Center of Pittsburgh and patients from 109 national burn centers who had burns limited to their lower extremities and required skin grafting, with no medical illnesses that would affect wound healing. Any excisional defect on the lower limb requiring grafting where a suitable full thickness donor site was available. Lorello et al (2014) Australia 10 Harvey et al (2007) 5 ≥18 years old, LE burn, ambulating a minimum of 2x/day with PT prior to autograft placement 8 English-language, human subject, clinical trial 6 4 LOS:!length!of!stay! N:!number!of!subjects! POD:!!postOop!day! Patients from the Plastic and Reconstructive Surgery Department at Royal Perth Hospital over a 6-month period. All studies providing original data on patients with LE wounds that required grafting Luczak et al (2012) Australia Nedelec et al (2012) Canada Smith, TO (2006) RCT or prospective cohort studies with split skin grafting to leg lacerations, early mobilization vs bed rest interventions, and outcome of graft healing. All types of skin defects including patients with questionable peripheral arterial circulation and diabetics. 2 Southwell-Keely et al (2011) Australia Wallenberg L (1999) Sweden 9 ABBREVIATIONS D/C:!discharge! EAG:!early!ambulation!group! LE:!lower!extremity! ! Exclusion Criteria Medical illnesses that would affect wound healing (e.g. vascular insufficiency). Excess adiposity where grafting to deep fascia would be too technically difficult or leave unacceptable cosmetic results. < 18 years old, diabetes mellitus (or increased levels of HgB A1C during hospitalization), peripheral vascular disease, lower extremity pitting edema ≥2+, cellulitis before surgery, nonambulatory before surgery. Multi-trauma patients, other factors resulting in limited mobility, burns >10% TBSA. Non-English or French, non-reviews, non-full length articles Cadaver studies, case reports, abstracts, letters, comments, editorials, review articles, unpublished, and non-English. Non-English studies, lower level studies Those in wheelchairs and the demented. SAG:!standard!ambulation!group! STSG:!SplitOthickness!skin!graft! 21! ! Intervention – Evidence Appraisal Worksheet Citation: Burnsworth B, Krob MJ, Langer-Schnepp M. Immediate ambulation of patients with lower-extremity grafts. J Burn Care Rehabil. 1992; 13: 89-92. Level of Evidence (Oxford scale): 4 Is the purpose and background information sufficient? Appraisal Criterion Study Purpose Reader’s Comments Stated clearly? Usually stated briefly in abstract and in greater detail in introduction. May be phrased as a question or hypothesis. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Yes. To assess the effects of Mercy Hospital’s early ambulation protocol, we compared it to patients with burns treated in other burn centers. Literature Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Traditional practices for lower extremity skin grafting include bed rest for several days despite literature advocating a less restrictive postoperative course. This article is to look into how accepted early ambulation practices are in burn centers nationally. Describe the justification of the need for this study Does the research design have strong internal validity? Appraisal Criterion ! ! Discuss possible threats to internal validity in the research design. Include: ! Assignment ! Attrition ! History ! Instrumentation ! Maturation ! Testing ! Compensatory Equalization of treatments Reader’s Comments The two groups were from different facilities. Unknown whether 12 patients who did not require PT because they ambulated >30’ immediately post-op were included in the study. Age, sex, and cause of injury between groups was similar. No compensation was provided to patients. Student’s t test was used. 22! ! ! ! Compensatory rivalry Statistical Regression Are the results of this therapeutic trial valid? Appraisal Criterion 1. 2. 3. 4. 5. 6. 7. 8. ! Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study’s results? Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study’s results? Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar – what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results Did the investigators know to which treatment group subjects were assigned? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study’s results? Was the subject follow-up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study’s results? Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? Reader’s Comments No. Assignment to group was determined by the hospital subjects were admitted to. This may alter the type of patient assigned to each group based on demographics of each burn center. The investigators were not blinded, however they were only reviewing past medical records. Yes, the groups were similar and demographics reported. Subjects followed the protocol of that particular hospital. This study was retrospective so subjects were not in a study at the time of their treatment. Yes, however they are only reviewing data. Most likely no because patient data was collected from 110 burn clinics across the country. No, subjects were only followed up to the discharge from the hospital. Only those subjects with complete medical records were included. The 12 subjects who ambulated >30’ immediately postop and did not get referred to PT were most likely not 23! ! c. 9. What are the implications of the attrition and the way it was handled with respect to the study’s findings? Were all patients analyzed in the groups to which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study’s results? included in the study. Those 12 subjects may be healthier and not including them could skew the data. Yes. Are the valid results of this RCT important? Appraisal Criterion 10. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With pvalues and CI c. Include effect size with p-values and CI d. Include ARR/ABI and RRR/RBI with pvalues and CI e. Include NNT and CI f. Other stats should be included here 11. What is the meaning of these statistical findings for your patient/client’s case? What does this mean to your practice? 12. Do these findings exceed a minimally important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? Reader’s Comments Average graft take 96.4% EAG vs survey: Ambulate >30’ 1.7 vs 7.2 days (p<0.001) D/C 6.9 vs 9.4 days (p<0.01) LOS: 10.2 vs 12.6 days (p<0.012) For uncomplicated patients early ambulation was not found to affect graft take. The MCID was not addressed. Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion 13. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3rd party coverage to provide this treatment? 14. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 15. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? 16. Does the intervention fit within your patient/client’s stated values or expectations? a. If not, what will you do now? ! Reader’s Comments Yes, the intervention sounds appropriate for use, requires no additional skills, equipment, or costs. Yes, some of my patients meet the inclusion criteria of this study. Benefits include patients able to walk further sooner, are discharged sooner, and have shorter hospital length of stays. The risk of graft failure was no different between groups. Yes. Patients want to walk and go home as soon as possible. 24! ! 17. Are there any threats to external validity in this study? No. What is the bottom line? Appraisal Criterion Reader’s Comments PEDRO score (see scoring at end of form) 7/10 Summarize your findings and relate this back to clinical significance ! The results of this retrospective study indicate that for a small proportion of burn patients an early ambulation protocol may be advised. Those patients with limited lower extremity burns requiring skin grafting to an average of 4% TBSA, who do not have medical illnesses that may impact wound healing, can begin ambulating immediately upon recovery from anesthetic without compromising graft healing. Another benefit includes decreased hospital stays. This study, like literature before it, has found that graft healing is not impacted by ambulation protocols, therefore, patients can be ambulated earlier, avoid potential secondary complications of bed rest, and open up space in burn centers for more complex patients. 25! ! Pedro Scoring System: Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA 2008 ! 26! ! Burnsworth B, Krob MJ, Langer-Schnepp M. Immediate ambulation of patients with lower-extremity grafts. J Burn Care Rehabil. 1992; 13: 89-92. Level of Evidence: Oxford Level 4 Background: Patients following lower extremity graft surgeries are typically put on bed rest for an average of 4.8 days despite the literature advocating for earlier ambulation protocols. Purpose: The purpose of this study was to assess the effects of Mercy Hospital’s early ambulation protocol for patients with lower extremity burns as compared to patients treated in other burn centers following the standard ambulation protocol. Methods: Patient records were reviewed for all patients admitted to Mercy Hospital with lower extremity burns requiring skin grafting, and who had no medical illnesses that could affect wound healing. All patients at Mercy Hospital followed the same surgical procedure; they were then encouraged to ambulate upon recovery from anesthetic without assistive devices. Questionnaires were sent to 173 burn centers, collecting information on dressing methods, ambulation practices, use of assistive devices, and hospital length of stay. Results: Fifty-eight Mercy patients were reviewed and 109 burn centers responded (63% response rate). Average graft take was 96.4%. The statistically significant results between the early ambulation group and the survey group are as follows: ambulating >30’ by 1.7 vs 7.2 days (p<0.001), discharge at 6.9 vs 9.4 days (p<0.01), length of hospital stay of 10.2 vs 12.6 days (p<0.012). Bottom Line: Early ambulation protocols may be followed for patients with limited lower extremity burns requiring skin grafting, who do not have medical illnesses that may impact wound healing. ! ! ! 27! ! Intervention – Evidence Appraisal Worksheet Citation: Harvey I, Smith S, Patterson I. The use of quilted full thickness skin grafts in the lower limb: reliable results with early mobilization. J of Plastic, Reconstructive & Aesthetic Surgery. 2009; 62; 969-972. Level of Evidence (Oxford scale): 4 Is the purpose and background information sufficient? Appraisal Criterion Study Purpose Reader’s Comments Stated clearly? Usually stated briefly in abstract and in greater detail in introduction. May be phrased as a question or hypothesis. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? The purpose was not clearly stated. The purpose was to show that using quilted full thickness skin grafts on the lower limbs allows for early ambulation without graft loss. Literature Background literature was provided and describes the lack of research into using this particular graft type on the lower extremities. Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Describe the justification of the need for this study Does the research design have strong internal validity? Appraisal Criterion ! ! Discuss possible threats to internal validity in the research design. Include: ! Assignment ! Attrition ! History ! Instrumentation ! Maturation ! Testing ! Compensatory Equalization of treatments Reader’s Comments Assignment: There was no control group. 60 consecutive patients had this procedure preformed. Attrition: 5 patients (7 grafts) did not return for the 2 week follow up. History: Mean age, and number of patients on particular medications was provided. 28! ! ! ! Compensatory rivalry Statistical Regression Instrumentation: The surgery was described in detail. No mention of how graft take was measured. Are the results of this therapeutic trial valid? Appraisal Criterion 18. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study’s results? 19. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study’s results? 20. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar – what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? 21. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 22. Did the investigators know to which treatment group subjects were assigned ? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 23. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study’s results? 24. Was the subject follow-up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study’s results? 25. Did all the subjects originally enrolled complete the study? ! Reader’s Comments N/A due to lack of control group N/A due to lack of control group N/A due to lack of control group N/A due to lack of control group Yes, as all the patients received the same treatment. N/A due to lack of control group Yes. No. 5 patients, with 7 total grafts, did not return for the 2 29! ! a. b. If not how many subjects were lost? What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study’s findings? 26. Were all patients analyzed in the groups to which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study’s results? week follow-up. These patients were not included in the study. N/A due to lack of control group Are the valid results of this RCT important? Appraisal Criterion Reader’s Comments 27. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With pvalues and CI c. Include effect size with p-values and CI d. Include ARR/ABI and RRR/RBI with pvalues and CI e. Include NNT and CI f. Other stats should be included here At 2nd week follow up: 100% graft take = 89.4%, 70-99% graft take = 5.9%, 50% graft take = 1.2%, 40% graft take = 1.2%, 0% graft take = 2.4% 28. What is the meaning of these statistical findings for your patient/client’s case? What does this mean to your practice? This particular surgery was not performed on my patient, my patient is much younger than the mean age in this study, and the reason for grafting is different. The findings are not relevant to my patient or practice. MCID was not discussed. 29. Do these findings exceed a minimally important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion 30. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3rd party coverage to provide this treatment? 31. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 32. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? ! Reader’s Comments The current surgeons use alternative grafting procedures. If they chose this type it would be easy to implement the early ambulation and discharge done in the study. The subjects are much older and the graft reason was different from my patient. No other information on the patients was provided. The intervention could be carried over. Yes. 30! ! 33. Does the intervention fit within your patient/client’s stated values or expectations? a. If not, what will you do now? Yes. 34. Are there any threats to external validity in this study? Yes. What is the bottom line? Appraisal Criterion Reader’s Comments PEDRO score (see scoring at end of form) 2/10 Summarize your findings and relate this back to clinical significance 60 patients with a total of 92 lesions on their lower limbs received quilted full thickness skin grafts. Of the 55 patients who returned at the 2 week follow up, 89.4% were completely healed, with another 5.9% between 7099% healed. All patients had two layers of “tubigrip” applied and were on bed rest with bathroom privileges for POD 1. On POD 2 they were discharged home and ambulated freely. This study shows the graft take results from one particular type of graft surgery with early ambulation and compression wrapping performed. It is not the typical surgery performed at my clinic, however the results may be generalized with caution to other grafts and are positive for an early ambulation protocol. ! 31! ! Pedro Scoring System: Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA 2008 ! 32! ! Harvey I, Smith S, Patterson I. The use of quilted full thickness skin grafts in the lower limb: reliable results with early mobilization. J of Plastic, Reconstructive & Aesthetic Surgery. 2009; 62; 969-972. Level of Evidence: Oxford Level 4 Background: Grafts to the lower extremities present greater challenges due to the dependent positioning and increased shear forces present during ambulation. Quilted full thickness skin grafts have been used primarily for nipple reconstruction and in the oral cavity, with more recent use on the face and hands to prevent seroms, hematomas, and shearing. Purpose: To perform quilted full thickness skin grafts on patients with lower extremity lesions, followed by early ambulation and assess graft healing. Methods: 60 patients with a total of 92 lesions on their lower limbs received quilted full thickness skin grafts. All patients had two layers of “tubigrip” applied and were on bed rest with bathroom privileges for POD 1. On POD 2 they were discharged home and ambulated freely. Results: Of the 55 patients/ 85 grafts who returned at the 2 week follow up, 89.4% were completely healed, 5.9% were 70-99% healed, 1.2% were 50% healed, 1.2% were 40% healed, and 2.4% had total graft loss. Bottom Line: The use of quilted full thickness skin grafts on lower extremity lesions followed by early ambulation in the older population had positive graft healing results in this study. ! ! ! 33! ! Intervention – Evidence Appraisal Worksheet Citation: Lorello DJ, Peck M, Albrecht M, Richey KJ, Pressman MA. Results of a prospective randomized controlled trial of early ambulation for patients with lower extremity autografts. J Burn Care & Research. 2014; 35, 5: 431-436. Level of Evidence (Oxford scale): 1b Is the purpose and background information sufficient? Appraisal Criterion Study Purpose Stated clearly? Usually stated briefly in abstract and in greater detail in introduction. May be phrased as a question or hypothesis. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Literature Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Reader’s Comments Yes. Hypothesis: Patients who begin ambulation within 24 hours of lower extremity autografting will have no increased risk of graft failure than those patients who remain immobile until POD 5. Past research uses the Unna boot for compression instead of the current use of ace figure of 8 wrapping. Research shows inherent risks of immobility. No prior RCTs consisting solely of burn patients. Describe the justification of the need for this study Does the research design have strong internal validity? Appraisal Criterion ! ! Discuss possible threats to internal validity in the research design. Include: ! Assignment ! Attrition ! History ! Instrumentation ! Maturation ! Testing Reader’s Comments Random assignment of subjects. Attrition rate of 25%. 10 subjects either did not return after discharge or ambulated prior to POD 5 but were assigned to the standard ambulation group. Excluding these subjects could skew the data. 34! ! ! ! ! Compensatory Equalization of treatments Compensatory rivalry Statistical Regression No testing was conducted, only tracking ambulation dates and times, and using VAS for pain ratings. No compensation was provided to subjects for participation. Are the results of this therapeutic trial valid? Appraisal Criterion 35. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study’s results? 36. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study’s results? 37. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar – what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? 38. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 39. Did the investigators know to which treatment group subjects were assigned ? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 40. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study’s results? 41. Was the subject follow-up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential ! Reader’s Comments Yes. Randomized assignment into ambulation group at completion of surgery. Randomized allocation decreases risk for bias. A burn surgeon who reviewed images of grafts to determine if any graft loss occurred was blinded. Yes the groups were similar with no statistically significant difference between groups. Demographics and burn histories were provided in a table. Yes. Subjects were not blinded to group allocation. Subjects may act differently depending upon which group they are assigned and skew some of the results. Yes. Yes. Yes. Patients seen weekly for 3 weeks after discharge. 35! ! consequences of this knowledge for the study’s results? 42. Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study’s findings? 43. Were all patients analyzed in the groups to which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study’s results? No. 41 patients enrolled, however 10 subjects were not included either because they did not return after discharge or they were randomized to the standard ambulation group, but ambulated before POD 5. No. 10 subjects were not included in the study because they either did not show up for follow-ups after discharge or because they ambulated earlier than POD 5 and were randomized into the standard ambulation group. Excluding this data can skew the results in either direction. Are the valid results of this RCT important? Appraisal Criterion 44. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With pvalues and CI c. Include effect size with p-values and CI d. Include ARR/ABI and RRR/RBI with pvalues and CI e. Include NNT and CI f. Other stats should be included here 45. What is the meaning of these statistical findings for your patient/client’s case? What does this mean to your practice? 46. Do these findings exceed a minimally important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? Reader’s Comments No statistical difference in graft loss. Percentage of graft loss: EAG 1.0% vs SAG 7.7% (p=0.0376) Mean minutes of ambulation on POD 5: EAG 23.4 minutes vs SAG 12.03 minutes (p=0.0235) Donor and graft site pain: EAG 1.3/10 vs SAG 3.14/10 on the VAS (p=0.0243) In patients that fit the inclusion criteria, it may be safe to begin ambulation immediately following graft surgery with no statistical affect on graft healing, but with benefits of increased ambulation times and decreased pain. The MCID was not mentioned, however the risks appear low and this protocol may be beneficial for a select group of patients. Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion 47. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3rd party coverage to provide this treatment? 48. Are the study subjects similar to your patient/ ! Reader’s Comments Yes. This intervention is simply providing the same intervention sooner to patients instead of waiting 5 days. Easy to implement. The subjects of this study are non-complex burn patients 36! ! client? a. If not, how different? Can you use this intervention in spite of the differences? 49. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? 50. Does the intervention fit within your patient/client’s stated values or expectations? a. If not, what will you do now? with a small TBSA% burned. They are a small minority of the patients seen at my clinical site, but they are present. Yes. Yes. My patients want to go to the bathroom independently, walk around, and go home as soon as possible. 51. Are there any threats to external validity in this study? What is the bottom line? Appraisal Criterion Reader’s Comments PEDRO score (see scoring at end of form) 8/10 Summarize your findings and relate this back to clinical significance No difference was found in graft loss between the early ambulation group and the standard treatment group on POD 5 or on follow-up visits. A significant difference was found in the mean minutes each group could ambulate on POD 5 (EAG: 23.4 minutes vs STG: 14.1, p=0.235). The EAG reported decreased pain at the graft site during rest (EAG: 1.3/10 vs STG 3.5/10, p=0.0243). There was no difference in the length of stay for either group. These findings suggest that non-complex burn patients may ambulate on POD 1 without increased risk to graft healing. ! 37! ! Pedro Scoring System: Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA 2008 ! 38! ! Lorello DJ, Peck M, Albrecht M, Richey KJ, Pressman MA. Results of a prospective randomized controlled trial of early ambulation for patients with lower extremity autografts. J Burn Care & Research. 2014; 35, 5: 431-436. Level of Evidence: Oxford 1b Background: Patients who undergo lower extremity skin grafting are commonly immobilized for five days over concerns of graft failure due to edema or shearing forces during the revascularization stage between 4-6 days post-op. There are also risks to immobilization including decreases in strength, orthostatic tolerance, and stroke volume and cardiac output. There are no prior randomized controlled trials on early ambulation of patients with lower extremity autografts in the burn population. Purpose: The objective of this study was to show that there is no change in graft healing between those who ambulated within 24 hours of lower extremity autografting and those immobilized for five days. Methods: 31 ambulatory patients over 18 years of age, without comorbidities affecting graft healing were randomly allocated to either a standard treatment group (n=14) or an early ambulation group (n=17). The early group (EAM) began ambulation on POD 1 versus POD 5 for the standard group (STG). Results: No difference was found in graft healing between groups on POD 5 or on follow-up visits. A significant difference was found in the mean minutes each group could ambulate on POD 5 (EAG: 23.4 minutes vs STG: 14.1, p=0.235). The EAG reported decreased pain at the graft site during rest (EAG: 1.3/10 vs STG 3.5/10, p=0.0243). There was no difference in the length of stay for either group. Bottom Line: Graft healing was not shown to be impacted by ambulation protocols and therefore, burn patients with lower extremity skin grafts can safely ambulate on POD 1. ! 39! ! Intervention – Evidence Appraisal Worksheet Citation: Luczak B, Ha J, Gurfinkel R. Effect of early and late mobilisation on split skin graft outcome. Australas J of Dermatol. 2012; 53: 19-21. Level of Evidence (Oxford scale): 2b Is the purpose and background information sufficient? Appraisal Criterion Study Purpose Reader’s Comments Stated clearly? Usually stated briefly in abstract and in greater detail in introduction. May be phrased as a question or hypothesis. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Yes. They hypothesize that early ambulation does not impact negatively on graft take, wound healing or adversely affect patient morbidity. Literature Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. There is a brief mention of the previous literature and the emerging trend towards early ambulation protocols within the research. Describe the justification of the need for this study Does the research design have strong internal validity? Appraisal Criterion ! ! Reader’s Comments Discuss possible threats to internal validity in the research design. Include: ! Assignment ! Attrition ! History ! Instrumentation ! Maturation ! Testing ! Compensatory Equalization of treatments 40! ! ! ! Compensatory rivalry Statistical Regression Are the results of this therapeutic trial valid? Appraisal Criterion 52. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study’s results? 53. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study’s results? 54. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar – what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? 55. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 56. Did the investigators know to which treatment group subjects were assigned ? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 57. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study’s results? 58. Was the subject follow-up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study’s results? 59. Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? ! Reader’s Comments No, it was a retrospective notes review. Allocation to group was determined by individual therapist. No Yes, the groups were similar. The only statistically significant difference was the number of burn patients allocated to the early mobilization group (18), compared to late mobilization (4) p=0.0002. N/A N/A Yes. Yes. Follow up was at day 5, with weekly clinic follow up until open wound care was achieved. Yes. 41! ! c. What are the implications of the attrition and the way it was handled with respect to the study’s findings? 60. Were all patients analyzed in the groups to which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study’s results? Yes. Are the valid results of this RCT important? Appraisal Criterion 61. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With pvalues and CI c. Include effect size with p-values and CI d. Include ARR/ABI and RRR/RBI with pvalues and CI e. Include NNT and CI f. Other stats should be included here Reader’s Comments Significant differences in deconditioning: 0 vs 6 (p=0.008), Post-op LOS: 3.92 vs 7.96 days (p=0.0001), Total LOS: 7.72 vs 13.57 days. No significant difference in graft loss: 88% vs 91% (p=0.45), infection (p=0.22), hematoma (p~1), or hypergranulation (p=0.24). 62. What is the meaning of these statistical findings for your patient/client’s case? What does this mean to your practice? The findings of this study indicate my non-complicated burn patient would benefit from early ambulation and the graft would not be negatively affected. 63. Do these findings exceed a minimally important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? MCID was not mentioned Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion 64. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3rd party coverage to provide this treatment? 65. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 66. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? 67. Does the intervention fit within your patient/client’s stated values or expectations? a. If not, what will you do now? ! Reader’s Comments Yes, the intervention is appropriate for some patients and requires no extra equipment or training. Yes. The subjects of this study are very similar to my patient. Yes. According to the results, there are only statistically significant benefits to this intervention. Yes, the patient wants to walk and go home as soon as possible without decreasing graft healing. 42! ! 68. Are there any threats to external validity in this study? No What is the bottom line? Appraisal Criterion Reader’s Comments PEDRO score (see scoring at end of form) 6/10 Summarize your findings and relate this back to clinical significance There was no difference found in graft loss 88% vs 91% (p=0.45), wound healing, or patient morbidity between groups, however the late mobilization group did have an increased rate of deconditioning 0 vs 6 (p=0.008), and increased length of hospital stay 3.92 vs 7.96 days (p=0.0001). Results suggest that early ambulation for lower extremity burn patients does not negatively impact graft healing and can decrease deconditioning and hospital stays. ! 43! ! Pedro Scoring System: Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA 2008 ! 44! ! Luczak B, Ha J, Gurfinkel R. Effect of early and late mobilisation on split skin graft outcome. Australas J of Dermatol. 2012; 53: 19-21. Level of Evidence: Oxford Scale 2b Background: There is an assumption that graft take and wound healing will be impaired by early ambulation, however there is an increasing amount of evidence to suggest this may not be the case. Purpose: This study hypothesizes that early mobilization does not negatively impact graft take, wound healing, or patient morbidity. They reviewed mobilization guidelines for patients with lower extremity splitthickness skin grafts by comparing early and late mobilization patients. Methods: A retrospective notes review of 48 subjects with lower extremity split thickness skin grafts was performed from Royal Perth Hospital over a 6-month period with patients placed into either an early or late mobilization group. Early mobilization was defined as less than or equal to 3 days of bed rest, late mobilization was defined as bed rest for greater than or equal to 4 days of bed rest with toilet privileges, mobilization was defined as unrestricted walking, and deconditioning was defined as a delay of discharge after an immobilization period secondary to poor mobility requiring rehab. Results: There was no difference found in graft loss 88% vs 91% (p=0.45), wound healing, or patient morbidity between groups, however the late mobilization group did have an increased rate of deconditioning 0 vs 6 (p=0.008), and increased length of hospital stay 3.92 vs 7.96 days (p=0.0001). Bottom Line: Results suggest that early ambulation for lower extremity burn patients does not negatively impact graft healing and can decrease deconditioning and hospital stays. ! 45! ! Systematic Review – Evidence Appraisal Worksheet Citation: Nedelec B, Serghiou MA, Niszczak J, McMahon M, Healey T. Practice guidelines for early ambulation of burn survivors after lower extremity grafts. J Burn Care Res. 2012; 33: 319-329. DOI: 10.1097/BCR.0b013e31823359d9 Level of Evidence (Oxford scale): 3a Does the design follow the Cochrane method? Appraisal Criterion Reader’s Comments Step 1 – formulating the question • Do the authors identify the focus of the review • A clearly defined question should specify the types of: • people (participants), • interventions or exposures, • outcomes that are of interest • studies that are relevant to answering the question Yes. Evaluate evidence of early ambulation of LE burns requiring skin grafts on graft healing. Step 2 – locating studies • Should identify ALL relevant literature • Did they include multiple databases? • Was the search strategy defined and include: o Bibliographic databases used as well as hand searching o Terms (key words and index terms) o Citation searching: reference lists o Contact with ‘experts’ to identify ‘grey’ literature (body of materials that cannot be found easily through conventional channels such as publishers) o Sources for ‘grey literature’ Yes Part 3:Critical Appraisal/Criteria for Inclusion • Were criteria for selection specified? • Did more than one author assess the relevance of each report • Were decisions concerning relevance described; completed by non-experts, or both? • Did the people assessing the relevance of studies know the names of the authors, institutions, journal of publication and results when they apply Yes. Two independent reviewers with a third reviewer as needed. ! 46! ! the inclusion criteria? Or is it blind? Part 3 – Critically appraise for bias: • Selection – • Were the groups in the study selected differently? • Random? Concealed? • Performance• Did the groups in the study receive different treatment? • Was there blinding? • Attrition – • Were the groups similar at the end of the study? • Account for drop outs? • Detection – • Did the study selectively report the results? • Is there missing data? Part 4 – Collection of the data • Was a collection data form used and is it included? • Are the studies coded and is the data coding easy to follow? • Were studies identified that were excluded & did they give reasons why (i.e., which criteria they failed). Sample sizes ranged from 9-100. RCTs ranged from 4475 subjects. The coding is clear. Reasons are provided for excluding studies. Are the results of this SR valid? Appraisal Criterion 69. Is this a SR of randomized trials? Did they limit this to high quality studies at the top of the hierarchies a. If not, what types of studies were included? b. What are the potential consequences of including these studies for this review’s results? 70. Did this study follow the Cochrane methods selection process and did it identify all relevant trials? a. If not, what are the consequences for this review’s results? 71. Do the methods describe the processes and tools used to assess the quality of individual studies? a. If not, what are the consequences for this review’s results? 72. What was the quality of the individual studies included? Were the results consistent from study to study? Did the investigators provide details about the research validity or quality of the studies included ! Reader’s Comments No. There are 4 RCTs, 1 Case-control study, and 11 case series were included. Yes Yes RCTs were Level 1b or 1c, Case series were Level 4. Results were consistent from study to study. 47! ! in review? 73. Did the investigators address publication bias Yes. Are the valid results of this SR important? Appraisal Criterion 74. Were the results homogenous from study to study? a. If not, what are the consequences for this review’s results? 75. If the paper is a meta-analysis did they report the statistical results? Did they include a forest plat? What other statistics do they include? Are there CIs? 76. From the findings, is it apparent what the cumulative weight of the evidence is? Reader’s Comments Yes Not a meta-analysis Isolating burns has a cumulative low weight of evidence Can you apply this valid, important evidence from this SR in caring for your patient/client? What is the external validity? Appraisal Criterion 77. Is your patient different from those in this SR? 78. Is the treatment feasible in your setting? Do you have the facilities, skill set, time, 3rd party coverage to provide this treatment? 79. Does the intervention fit within your patient/client’s stated values or expectations? a. If not, what will you do now? Reader’s Comments No Yes Yes What is the bottom line? Appraisal Criterion Reader’s Comments Summarize your findings and relate this back to clinical significance An early postoperative ambulation protocol should be initiated immediately, or as soon as possible, on patients who were previously ambulatory, are medically and psychologically stable, with wounds <300cm2 that are not on the plantar surface of the foot. External compression must be applied and any joints the graft crosses should be immobilized until the first dressing change. Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA 2008 ! 48! ! Nedelec B, Serghiou MA, Niszczak J, McMahon M, Healey T. Practice guidelines for early ambulation of burn survivors after lower extremity grafts. J Burn Care Res. 2012; 33: 319-329. DOI: 10.1097/BCR.0b013e31823359d9. Level of Evidence: Oxford Level 3a Background: Patients following lower extremity graft surgeries are typically put on bed rest for several days despite the literature advocating for earlier ambulation protocols. Practice guidelines do not yet exist and the reason for bed rest is most often fear of graft failure due to hematoma, shearing, or lack of graft adherence. Purpose: The purpose of this guideline was to review the evidence supporting early ambulation after lower extremity skin grafts and to determine when burn patients should being ambulating after skin grafting. Methods: To create practice guidelines they created a guideline development group, asked clinically relevant questions, performed an electronic literature search, and appraised the twenty-two articles included. Results: 4 RCTs, 1 Case-control study, and 11 case series were included. No RCTs contained only burn patients. All the studies contained elastic compression before ambulation. No studies found initiation of ambulation to have an impact on graft healing. Guidelines: An early postoperative ambulation protocol should be initiated immediately, or as soon as possible, on patients who were previously ambulatory, are medically and psychologically stable, with wounds <300cm2 that are not on the plantar surface of the foot. External compression must be applied and any joints the graft crosses should be immobilized until the first dressing change. ! ! 49! ! Systematic Review – Evidence Appraisal Worksheet Citation: Smith TO. When should patients begin ambulating following lower limb split skin graft surgery? A systematic review. Physiotherapy. 2006; 92: 135-145. Level of Evidence (Oxford scale): 2a Does the design follow the Cochrane method? Appraisal Criterion Reader’s Comments Step 1 – formulating the question • Do the authors identify the focus of the review • A clearly defined question should specify the types of: • people (participants), • interventions or exposures, • outcomes that are of interest • studies that are relevant to answering the question Yes. The objective “was to determine when patients should begin walking after lower extremity skin graft surgery, with consideration given to graft healing, duration to discharge, postoperative complications, functional outcomes, quality of life and patient satisfaction.” Studies/Participants: All clinical trials in English with human-subjects, no age or gender limitations. Intervention: ambulation, debridement, split-thickness skin graft, compression wrapping Outcomes: graft healing, duration to discharge, postoperative complications, functional outcomes, quality of life and patient satisfaction Step 2 – locating studies • Should identify ALL relevant literature • Did they include multiple databases? • Was the search strategy defined and include: o Bibliographic databases used as well as hand searching o Terms (key words and index terms) o Citation searching: reference lists o Contact with ‘experts’ to identify ‘grey’ literature (body of materials that cannot be found easily through conventional channels such as publishers) o Sources for ‘grey literature’ Part 3:Critical Appraisal/Criteria for Inclusion • Were criteria for selection specified? • Did more than one author assess the relevance of each report • Were decisions concerning relevance described; completed by non-experts, or both? • Did the people assessing the relevance of studies know the names of the ! Electronic database searches: AMED, Cinahl, Embase, Medline via Ovid, PEDro, and Pubmed. Search terms were given and strategy defined. Hand search through the reference lists of identified citations, as well as The British Journal of Plastic Surgery, and the Annals of Plastic Surgery and Physiotherapy from 1980-2006 for additional studies. No mention of contacting “experts” for grey literature. Did not include unpublished studies. Yes: Inclusion and exclusion criteria stated. No: A single, non-blinded reviewer performed the search and extracted data. 50! ! authors, institutions, journal of publication and results when they apply the inclusion criteria? Or is it blind? Part 3 – Critically appraise for bias: • Selection – • Were the groups in the study selected differently? • Random? Concealed? • Performance• Did the groups in the study receive different treatment? • Was there blinding? • Attrition – • Were the groups similar at the end of the study? • Account for drop outs? • Detection – • Did the study selectively report the results? • Is there missing data? Part 4 – Collection of the data • Was a collection data form used and is it included? • Are the studies coded and is the data coding easy to follow? • Were studies identified that were excluded & did they give reasons why (i.e., which criteria they failed). Selection: only 3 studies were randomized, none were concealed. Performance: no studies were blinded for subject or clinicians. Attrition: studies accounted for drop-outs Detection: not all studies gave thorough description of intervention protocols and other details that may skew results. A summary of the articles with key data including study design, population characteristics, average wound size, surgical and postoperative interventions undertaken, outcome measures applied, follow-up period, and results was included. Articles were easily identified by a coding of last name and a number. Excluded articles were not individually listed. Are the results of this SR valid? Appraisal Criterion 80. Is this a SR of randomized trials? Did they limit this to high quality studies at the top of the hierarchies a. If not, what types of studies were included? b. What are the potential consequences of including these studies for this review’s results? 81. Did this study follow the Cochrane methods selection process and did it identify all relevant trials? a. If not, what are the consequences for this review’s results? 82. Do the methods describe the processes and tools used to assess the quality of individual studies? a. If not, what are the consequences for this review’s results? ! Reader’s Comments No. Designs included: Retrospective review (9), Observational study (4), and RCT (4). Articles were rated using Pedro scores, with the highest receiving a 5. Overall the evidence was poor. No. Only one reviewer was used which Introduces bias during the article selection process. Articles were rated using the PEDro (Physiotherapy Evidence Database) scale, with the highest receiving a 5. Overall the evidence was poor. Studies were included even with considerable methodological limitations in an 51! ! attempt to evaluate the entirety of evidence. 83. What was the quality of the individual studies included? Were the results consistent from study to study? Did the investigators provide details about the research validity or quality of the studies included in review? 84. Did the investigators address publication bias Overall the quality of the individual studies was poor. Results were consistent from study to study. Details of each study’s validity were discussed. Yes. No attempt was made to identify unpublished studies. Are the valid results of this SR important? Appraisal Criterion 85. Were the results homogenous from study to study? a. If not, what are the consequences for this review’s results? 86. If the paper is a meta-analysis did they report the statistical results? Did they include a forest plat? What other statistics do they include? Are there CIs? 87. From the findings, is it apparent what the cumulative weight of the evidence is? Reader’s Comments Yes. Although the studies had a wide variety of in regards to initiation of ambulation, the results were homogenous in that graft healing was not significantly effected by either early or late ambulation. No meta-analysis due to paucity of trials for each postoperative day that patients were mobilized, and the heterogeneity of the study samples and data. Yes. The weight of the evidence is low and greater research is needed. Can you apply this valid, important evidence from this SR in caring for your patient/client? What is the external validity? Appraisal Criterion 88. Is your patient different from those in this SR? 89. Is the treatment feasible in your setting? Do you have the facilities, skill set, time, 3rd party coverage to provide this treatment? 90. Does the intervention fit within your patient/client’s stated values or expectations? b. If not, what will you do now? Reader’s Comments No. The SR covered wide age range, and cause of injury, similar to my patient population. More complex patients were not included. Yes, this treatment is feasible and could easily be implemented. Yes. Patients want to get out of bed, ambulate to the bathroom independently immediately, and go home as soon as possible. What is the bottom line? Appraisal Criterion Reader’s Comments Summarize your findings and relate this back to clinical significance The findings of this review suggest that patients should begin walking immediately, or at the earliest opportunity, after lower extremity split-thickness skin graft surgery. Although there is no evidence to suggest early ambulation improves graft healing, it does not jeopardize graft take significantly. Economic benefits and decrease activity restriction of patients also support early ! 52! ! ambulation. The conclusion of this review is based on low level evidence and requires further RCTs and higher level studies to determine the effectiveness of early ambulation for lower extremity skin graft patients and specific protocols, and contraindications. Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA 2008 ! ! ! ! ! 53! ! Smith TO. When should patients begin ambulating following lower limb split skin graft surgery? A systematic review. Physiotherapy. 2006; 92: 135-145. Level of Evidence: Oxford 2a Background: Traditionally, patients are immobilized for several days following split-thickness skin graft surgery. More recently there has been a push to ambulate patients earlier in order to avoid secondary medical complications associated with bed rest and to facilitate hospital discharge. Purpose: The purpose of this literature review was to determine when patients could begin ambulating following lower extremity split-thickness skin graft surgery. Graft healing, duration until discharge, postoperative complications, functional outcomes, quality of life, and patient satisfaction were considered. Methods: A literature search was conducted using the following electronic databases: AMED, Cinahl, Embase, Medline via Ovid, PEDro, and Pubmed. Reference lists of found articles were searched for further studies. A hand-search was conducted of The British Journal of Plastic Surgery and the Annals of Plastic Surgery and Physiotherapy from 1980-2006. From 1137 articles, 17 were chosen. A single reviewer performed the search, extracted the data, and scored the articles using the PEDro scale. Results: Articles were classified based upon earliest postoperative day ambulation, ranging from immediate ambulation to greater than one week. The quality of the evidence is generally poor. Bottom Line: The literature reviewed supports beginning ambulation immediately following lower extremity split-thickness skin graft surgery, as it appears to neither jeopardize nor improve graft healing, and may decrease hospital length of stay. Due to the poor quality of evidence, conclusions made from these findings should be reviewed with care. Further, higher quality studies are needed to address current weaknesses in the literature. ! 54! ! Systematic Review – Evidence Appraisal Worksheet Citation Southwell-Keely J, Vandervord J. Mobilisation versus bed rest after skin grafting pretibial lacerations: A meta-analysis. Plast Surg Int. 2012; 2012: 207452. doi: 10.1155/2012/207452. Level of Evidence (Oxford scale): 1a Does the design follow the Cochrane method? Appraisal Criterion Reader’s Comments Step 1 – formulating the question • Do the authors identify the focus of the review • A clearly defined question should specify the types of: • people (participants), • interventions or exposures, • outcomes that are of interest • studies that are relevant to answering the question Yes. The purpose of this study was to assess early mobilization versus bed rest on lower extremity skin graft healing. Step 2 – locating studies • Should identify ALL relevant literature • Did they include multiple databases? • Was the search strategy defined and include: o Bibliographic databases used as well as hand searching o Terms (key words and index terms) o Citation searching: reference lists o Contact with ‘experts’ to identify ‘grey’ literature (body of materials that cannot be found easily through conventional channels such as publishers) o Sources for ‘grey literature’ Yes. Medline, Embase, Cochrane, Cinahl, and Google Scholar databases were used, as were the bibliographies of selected studies cross-referenced. Search terms were not included. Experts were contacted in cases of missing data. Part 3:Critical Appraisal/Criteria for Inclusion • Were criteria for selection specified? • Did more than one author assess the relevance of each report • Were decisions concerning relevance described; completed by non-experts, or both? • Did the people assessing the relevance of studies know the names of the authors, institutions, journal of publication and results when they apply the inclusion criteria? Or is it blind? Yes, criteria were specified. Not stated if more than one author assessed each report. ! 55! ! Part 3 – Critically appraise for bias: • Selection – • Were the groups in the study selected differently? • Random? Concealed? • Performance• Did the groups in the study receive different treatment? • Was there blinding? • Attrition – • Were the groups similar at the end of the study? • Account for drop outs? • Detection – • Did the study selectively report the results? • Is there missing data? Groups were randomized. Interventions were the same between studies. Part 4 – Collection of the data • Was a collection data form used and is it included? • Are the studies coded and is the data coding easy to follow? • Were studies identified that were excluded & did they give reasons why (i.e., which criteria they failed). No, collection data form is not included. There are only 4 studies so coding was not used. Yes, a flow diagram was included with the reasoning behind excluded studies. Are the results of this SR valid? Appraisal Criterion 91. Is this a SR of randomized trials? Did they limit this to high quality studies at the top of the hierarchies a. If not, what types of studies were included? b. What are the potential consequences of including these studies for this review’s results? 92. Did this study follow the Cochrane methods selection process and did it identify all relevant trials? a. If not, what are the consequences for this review’s results? 93. Do the methods describe the processes and tools used to assess the quality of individual studies? a. If not, what are the consequences for this review’s results? 94. What was the quality of the individual studies included? Were the results consistent from study to study? Did the investigators provide details about the research validity or quality of the studies included in review? ! Reader’s Comments Four articles were analyzed including three randomized controlled trials and one prospective cohort study. Including the prospective cohort study may introduce bias, however sensitivity analyses were performed and the data results did not change. It followed the guidelines set out in the QUORUM statement and the CONSORT statement. Yes Not stated 56! ! 95. Did the investigators address publication bias Are the valid results of this SR important? Appraisal Criterion 96. Were the results homogenous from study to study? a. If not, what are the consequences for this review’s results? 97. If the paper is a meta-analysis did they report the statistical results? Did they include a forest plat? What other statistics do they include? Are there CIs? 98. From the findings, is it apparent what the cumulative weight of the evidence is? Reader’s Comments Yes Yes. A forest plat, odds ratios and CIs are included. Strength of evidence is not strong. Can you apply this valid, important evidence from this SR in caring for your patient/client? What is the external validity? Appraisal Criterion 99. Is your patient different from those in this SR? 100. Is the treatment feasible in your setting? Do you have the facilities, skill set, time, 3rd party coverage to provide this treatment? 101. Does the intervention fit within your patient/client’s stated values or expectations? c. If not, what will you do now? Reader’s Comments Yes, his graft is a result of a burn not a laceration. Yes. Yes. The patient would like to ambulate as soon as possible. What is the bottom line? Appraisal Criterion Reader’s Comments Summarize your findings and relate this back to clinical significance No difference in graft healing was found between the early mobilization groups and bed rest groups of either 7 or 14 days. No difference found in hematoma, bleeding, infection, or donor site healing rates between groups. Systemic corticosteroids significantly delayed graft healing. Graft healing is not effected by ambulation interventions, however the use of corticosteroids does have a significant negative effect on graft healing. Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA 2008 ! 57! ! Southwell-Keely J, Vandervord J. Mobilisation versus bed rest after skin grafting pretibial lacerations: A meta-analysis. Plast Surg Int. 2012; 2012: 207452. doi: 10.1155/2012/207452. Level of Evidence: Oxford Level 1a Background: Pretibial lacerations are most commonly managed with debridement and skin grafting followed by several days of postoperative bed rest. Purpose: The purpose of this study was to assess early mobilization versus bed rest on skin graft healing. Methods: An electronic database literature search was conducted and bibliographies of selected studies were cross-referenced. Four articles were analyzed including three randomized controlled trials and one prospective cohort study. Results: No difference in graft healing was found between the early mobilization groups and bed rest groups of either 7 or 14 days. No difference found in hematoma, bleeding, infection, or donor site healing rates between groups. Systemic corticosteroids significantly delayed graft healing. Bottom Line: Graft healing is not effected by ambulation interventions, however the use of corticosteroids does have a significant negative effect on graft healing. ! 58! ! Intervention – Evidence Appraisal Worksheet Citation: Wallenberg L. Effect of early mobilization after skin grafting to lower limbs. Scand J Plast Reconstr Hand Surg. 1999; 33: 411-413. Level of Evidence (Oxford scale): 1c Is the purpose and background information sufficient? Appraisal Criterion Study Purpose Reader’s Comments Stated clearly? Usually stated briefly in abstract and in greater detail in introduction. May be phrased as a question or hypothesis. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Yes. The purpose of this prospective, randomized study was to determine whether strict bed rest is required after split-thickness skin graft surgery to the lower extremities. Literature Only two previous studies are referenced. A thorough review of the literature was not reported. Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Describe the justification of the need for this study Does the research design have strong internal validity? Appraisal Criterion ! ! Discuss possible threats to internal validity in the research design. Include: ! Assignment ! Attrition ! History ! Instrumentation ! Maturation ! Testing ! Compensatory Equalization of treatments Reader’s Comments Assignment was randomized. Attrition rate was not mentioned. History between groups was insignificant according to Fisher’s exact test (p=0.7). Maturation: Subjects were reviewed at 14 days post-op. Testing: graft healing was evaluated by two blinded nurses. Compensation: no compensation was given to the 59! ! ! ! Compensatory rivalry Statistical Regression subjects. Are the results of this therapeutic trial valid? Appraisal Criterion 102. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study’s results? 103. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study’s results? 104. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar – what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? 105. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 106. Did the investigators know to which treatment group subjects were assigned ? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 107. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study’s results? 108. Was the subject follow-up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study’s results? 109. Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? ! Reader’s Comments Yes. Subjects were assigned to a group the afternoon after their operation by drawing paper slips from a box. There were a total of 50 paper slips, 25 with E (early) and 25 with L (late). No. The investigators were blinded. The groups were similar. They reported age, gender, and diagnosis. Unsure if the patients were told the study was looking at ambulation date, because if they had then the patients would obviously know what group they were assigned to. No. The two nurses were blinded. Yes, both groups were managed the same except for the intervention. Graft healing was assessed at 14 days post-op. Followup for a longer time would provide extra information, especially due to the complexity of the systemic diseases included in this study, however grafts would either be adhered or not by day 14. Not clearly stated, but it appears all subjects completed the study. 60! ! b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study’s findings? 110. Were all patients analyzed in the groups to which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study’s results? Not clearly stated, but it appears so. Are the valid results of this RCT important? Appraisal Criterion 111. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With pvalues and CI c. Include effect size with p-values and CI d. Include ARR/ABI and RRR/RBI with pvalues and CI e. Include NNT and CI f. Other stats should be included here 112. What is the meaning of these statistical findings for your patient/client’s case? What does this mean to your practice? 113. Do these findings exceed a minimally important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? Reader’s Comments There was no statistical difference in graft healing between the two groups. The three subjects with arterial leg ulcers did not heal in either group. The reason for unsuccessful graft takes might be explained by local factors or systemic diseases rather than by the time ambulation begins. The MCID was not mentioned. Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion 114. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3rd party coverage to provide this treatment? 115. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 116. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? 117. Does the intervention fit within your patient/client’s stated values or expectations? a. If not, what will you do now? ! Reader’s Comments Yes the intervention is appropriate for my clinical setting. Yes. This study included patients with a variety of diseases with LE grafts which is similar to my patient population. Yes. This study did not show that a change in ambulation practice impacts graft healing, so there is little risk. Yes. Patients want their grafts to heal along with a short hospital stay. 61! ! 118. Are there any threats to external validity in this study? Small sample size. What is the bottom line? Appraisal Criterion Reader’s Comments PEDRO score (see scoring at end of form) 7/10 Summarize your findings and relate this back to clinical significance ! This study had a sample size of 50 subjects with a variety of systemic diseases and reasons for requiring lower extremity skin grafts. The early ambulation group began a graded ambulation protocol on POD 1 whereas the late ambulation group began walking after four days of bed rest. There was no significant difference in graft healing between the two groups. Three patients with arterial leg ulcers did not heal after grafting and neither did two patients with graft site infections. All trauma wounds healed. It appears that the reason for unsuccessful take of grafts might be explained by local factors or systemic disease rather than by the time ambulation began. 62! ! Pedro Scoring System: Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA 2008 ! 63! ! Wallenberg L. Effect of early mobilization after skin grafting to lower limbs. Scand J Plast Reconstr Hand Surg. 1999; 33: 411-413. Level of Evidence: Oxford Level 1c Background: The subject of ambulating subjects with lower extremity grafts has been studied before. Wallenberg mentions two previous studies, one in which there was no late ambulation control group, and a second small study that found no difference in graft healing between the early and late ambulation groups. Purpose: The purpose of this prospective, randomized study was to determine whether strict bed rest for four to eight days is required after split-thickness skin grafts to the lower extremity as is traditionally done. Methods: Fifty consecutive patients requiring split-thickness skin grafting to areas below the inguinal ligament were randomized into either an early ambulation or a late ambulation group. All types of skin defects were included in the study including peripheral arterial circulation issues and diabetes. Subjects in the early ambulation group began a graded protocol on the day after surgery. Day one the patients stood and took steps for two minutes, three times a day. Day two, they ambulated for five minutes, three times a day. On day three they ambulated for ten minutes, three times a day, and on day four they had unrestricted ambulation. The late ambulation group was on bed rest for four days and on day five began the same graded protocol. Graft healing was assessed by two blinded nurses on post-op day fourteen. Results: There was no significant difference in graft healing between the two groups. Grafts were healed in 80% of the early ambulation group and 88% in the late ambulation group. Three patients with arterial leg ulcers did not heal after grafting and neither did two patients with graft site infections. All trauma wounds healed. Thirty-one subjects required antibiotics. Bottom Line: The reason for unsuccessful graft take might be better explained by local factors or systemic diseases rather than by the time ambulation begins. ! 64!
© Copyright 2024 Paperzz