CE ONLINE Technology Advancements: NOT Yesterday’s Suture A Continuing Education Activity Sponsored By Grant Funds Provided By Welcome to Technology Advancements: NOT Yesterday’s Suture (An Online Continuing Education Activity) CONTINUING EDUCATION INSTRUCTIONS This educational activity is being offered online and may be completed at any time. Steps for Successful Course Completion To earn continuing education credit, the participant must complete the following steps: 1. Read the overview and objectives to ensure consistency with your own learning needs and objectives. At the end of the activity, you will be assessed on the attainment of each objective. 2. Review the content of the activity, paying particular attention to those areas that reflect the objectives. 3. Complete the Test Questions. Missed questions will offer the opportunity to reread the question and answer choices. You may also revisit relevant content. 4. For additional information on an issue or topic, consult the references. 5. To receive credit for this activity complete the evaluation and registration form. 6. A certificate of completion will be available for you to print at the conclusion. Pfiedler Enterprises will maintain a record of your continuing education credits and provide verification, if necessary, for 7 years. Requests for certificates must be submitted in writing by the learner. If you have any questions, please call: 720-748-6144. CONTACT INFORMATION: © 2014 All rights reserved Pfiedler Enterprises, 2101 S. Blackhawk Street, Suite 220, Aurora, Colorado 80014 www.pfiedlerenterprises.com Phone: 720-748-6144 Fax: 720-748-6196 OVERVIEW Preventing surgical site infections (SSIs) is a primary goal for all members of the perioperative team; this is takes on greater significance in light of implementation of the Affordable Care Act (ACA). Today, SSIs remain a major source of clinical complications and therefore are associated with significant economic consequences. In this regard, effective wound closure is essential for reducing the risk for SSIs and thus achieving optimal surgical outcomes. The evolution of suture technology has paralleled developments in the practice of surgery; this continues today as technological advancements in sutures, specialty needles, and topical skin adhesives have resulted in exciting new options to support contemporary surgical techniques and also offer distinct clinical and economic benefits. This continuing education activity will present a review of technological advances in suture, needle, and topical skin adhesive technology. The importance of effective wound closure and the appropriate selection of sutures, tissue control devices, specialty needles, and topical skin adhesives used for wound closure will be discussed. It will outline the initiatives in the ACA that incentivize health care facilities to reduce SSIs and readmissions. The differences between traditional sutures and selected advanced sutures, tissue control devices, and specialty needles will be discussed. Advances in topical skin adhesives, including their efficacy in preventing SSIs will be reviewed. The clinical and economic benefits associated with the use of technologically advanced sutures and specialty needles will be outlined. OBJECTIVES After completing this continuing nursing education activity, the participant should be able to: 1. Identify the initiatives outlined in the ACA related to SSIs and readmissions. 2. Differentiate between traditional sutures and technologically advanced sutures. 3. Discuss the science and technology behind advanced sutures, tissue control devices, specialty needles, and topical skin adhesives. 4. Describe how technological advancements in sutures, tissue control devices, and specialty needles improve clinical outcomes. 5. Discuss advances in topical skin adhesives and their role in preventing SSIs. 6. List the economic benefits of today’s advanced sutures and specialty needles in light of the ACA. INTENDED AUDIENCE This continuing education activity is intended for perioperative registered nurses interested in learning more about technological advancements in sutures, specialty needles, and topical skin adhesives in order to improve clinical and economic outcomes. 3 Credit/Credit Information State Board Approval for Nurses Pfiedler Enterprises is a provider approved by the California Board of Registered Nursing, Provider Number CEP14944, for 2.0 contact hours. Obtaining full credit for this offering depends upon attendance, regardless of circumstances, from beginning to end. Licensees must provide their license numbers for record keeping purposes. The certificate of course completion issued at the conclusion of this course must be retained in the participant’s records for at least four (4) years as proof of attendance. IACET Pfiedler Enterprises has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET). CEU Statements • As an IACET Authorized Provider, Pfiedler Enterprises offers CEUs for its programs that qualify under the ANSI/IACET Standard. • Pfiedler Enterprises is authorized by IACET to offer 0.2 CEUs for this program. Release and Expiration Date This continuing education activity was planned and provided in accordance with accreditation criteria. This material was originally produced in June 2014 and can no longer be used after June 2016 without being updated; therefore, this continuing education activity expires June 2016. DISCLAIMER Accredited status as a provider refers only to continuing nursing education activities and does not imply endorsement of any products. SUPPORT Funds to support this activity have been provided by Ethicon. 4 Authors/Planning Committee/Reviewer Elizabeth Deroian, BA, RN Program Manager/Planning Committee Pfiedler Enterprises Aurora, CO Judith I. Pfister, MBA, RN Program Manager/Planning Committee Pfiedler Enterprises Aurora, CO Rose Moss, MN, RN, CNOR Nurse Consultant/Author Moss Enterprises Elizabeth, CO Julia A. Kneedler, EdD, RN Program Manager/Reviewer Pfiedler Enterprises Aurora, CO Disclosure of Relationships with Commercial Entities for Those in a Position to Control Content for this Activity Pfiedler Enterprises has a policy in place for identifying and resolving conflicts of interest for individuals who control content for an educational activity. Information below is provided to the learner, so that a determination can be made if identified external interests or influences pose potential bias in content, recommendations or conclusions. The intent is full disclosure of those in a position to control content, with a goal of objectivity, balance and scientific rigor in the activity. For additional information regarding Pfiedler Enterprises’ disclosure process, visit our website at: http://www. pfiedlerenterprises.com/disclosure Disclosure includes relevant financial relationships with commercial interests related to the subject matter that may be presented in this continuing education activity. “Relevant financial relationships” are those in any amount, occurring within the past 12 months that create a conflict of interest. A commercial interest is any entity producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients. Activity Authors/ Planning Committee/Reviewer Elizabeth Deroian, BA, RN No conflict of interest Rose Moss, MN, RN, CNOR No conflict of interest Judith I. Pfister, MBA, RN Co-owner of company that receives grant funds from commercial entities Julia A. Kneedler, EdD, RN Co-owner of company that receives grant funds from commercial entities 5 PRIVACY AND CONFIDENTIALITY POLICY Pfiedler Enterprises is committed to protecting your privacy and following industry best practices and regulations regarding continuing education. The information we collect is never shared for commercial purposes with any other organization. Our privacy and confidentiality policy is covered at our website, www.pfiedlerenterprises.com, and is effective on March 27, 2008. To directly access more information on our Privacy and Confidentiality Policy, type the following URL address into your browse: http://www.pfiedlerenterprises.com/privacy-policy In addition to this privacy statement, this Website is compliant with the guidelines for internet-based continuing education programs. The privacy policy of this website is strictly enforced. CONTACT INFORMATION If site users have any questions or suggestions regarding our privacy policy, please contact us at: Phone: 720-748-6144 Email: [email protected] Postal Address: 2101 S. Blackhawk Street, Suite 220 Aurora, Colorado 80014 Website URL: http://www.pfiedlerenterprises.com 6 INTRODUCTION Infection prevention is a primary goal for all patients undergoing surgery: one of the expected outcomes for surgical intervention is that the patient is free from signs and symptoms of infection.1 Therefore, preventing surgical site infections (SSIs) is a primary goal for all members of the perioperative team. However, despite awareness of the problem and the advances that have been made in various infection prevention practices (eg, surgical technique and antimicrobial prophylaxis), SSIs remain a substantial cause of prolonged hospitalization, morbidity, and mortality.2 The Centers for Disease Control and Prevention (CDC) reports that in 2010, an estimated 16 million operative procedures were performed in the United States.3 On an annual basis, SSIs are reported to be the most frequent health care-associated infection (HAI), accounting for 36% of HAIs nationwide.4 The estimated 300,000 SSIs that occur annually in the United States prolong hospitalization by 7 to10 days; in addition, the mortality rate associated with SSIs is 3%, with approximately 75% of deaths being directly attributable to the infection.5 A recently published meta-analysis of the costs and financial impact of HAIs, in terms of attributable costs and lengths of stay on the United States health care system, reported that SSIs were the third most costly HAI at $20,785.6 The total annual costs for the five major infections (SSIs, central line-associated bloodstream infections, catheter-associated urinary tract infections, ventilator-associated pneumonia, and Clostridium difficile infections) were $9.8 billion (ranging from $8.3 to $11.5 billion), with SSIs contributing the most to overall costs (33.7% of the total costs). The economic impact of SSIs is especially significant in light of the 2010 Affordable Care Act (ACA), which includes policies and other initiatives to help health care facilities and providers improve the safety and quality of patient care and also reduce costs. THE IMPACT OF POLICY CHANGES IN THE AFFORDABLE CARE ACT (ACA) ON SSIs Because the clinical and economic burdens associated with SSIs are significant, federal initiatives are currently in place to incentivize hospitals and health care facilities to improve the quality of care by reducing SSIs, other hospital-acquired conditions, and hospital readmissions through limits on reimbursement, public reporting, and penalties. Since 2008, the Centers for Medicare & Medicaid (CMS) has included SSI in its list of hospital-acquired conditions (HACs) for which reimbursement will not be provided.7 Hospital-acquired conditions are defined by CMS as those that: • Are high cost, high volume, or both; • Result in the assignment of the case to a Medicare Severity Diagnosis Related Group (MS-DRG) which has a higher payment when it present as a secondary diagnosis; and • Could reasonably have been prevented with the application of evidence-based guidelines. For discharges that occurred on or after October 1, 2008, hospitals no longer received additional reimbursement for cases in which one of the selected conditions was not present 7 on admission, ie, the case is paid as if the secondary diagnosis were not present. In addition, as of 2014, hospitals must report their SSI rates to CDC’s National Healthcare Safety Network (NHSN) to receive maximum reimbursement.8 In response to ongoing initiatives to improve the quality and safety of patient care, CMS continues to update its rulings on payments to hospitals and health care providers based on the quality of care, not just the quantity of the services they provide according to provisions in the ACA. On August 2, 2013, CMS issued a final rule that updated Medicare payment policies and rates under the Inpatient Prospective Payment System (IPPS) in fiscal year (FY) 2014; this rule will affect discharges that occurred on or after October 1, 2013.9 In addition to setting the standards for payments for Medicare-covered inpatient services, the FY 2014 hospital payment rule describes the process for implementing a new HAC Reduction Program, which will take effect in FY 2015. The ACA requires CMS to establish a program for IPPS hospitals to improve patient safety by imposing financial penalties on those hospitals that perform poorly in regards to HACs, ie, conditions that a patient did not have upon admission to the hospital, but which developed during the course of his/her hospital stay. Beginning in FY 2015 under the HAC Reduction Program, hospitals that rank in the lowest-performing quartile of HACs will be paid 99% of what they otherwise would have been paid, ie, they will be levied a 1% penalty. The ACA also established the Hospital Readmissions Reduction Program, which requires CMS to reduce payments to hospitals with excess readmissions; this became effective for discharges as of October 1, 2012.10 Readmission is defined by CMS as an admission to a hospital within 30 days of a discharge from the same or another hospital. In light of the significant clinical consequences of SSIs and their expanding economic implications, the responsibility for reducing every patient’s risk for SSI through optimal wound closure and healing is more important than ever. Excellent surgical technique, which encompasses gentle handling of tissue, using suture material appropriately, and effective management of the incision postoperatively, is commonly believed to reduce the a patient’s risk for SSI.11 Today, technological advancements in sutures, needles, and topical skin adhesive products can assist perioperative personnel in implementing effective infection control strategies to prevent SSIs and realize clinical and economic benefits. TRADITIONAL SUTURE MATERIALS AND SURGICAL NEEDLES Historical Overview The use of sutures dates back to the earliest human knowledge of the practice of surgery.12 Throughout history, various types of materials have been used for closing and suturing surgical wounds; these include the oldest suture materials, such as animal tendons and hairs, as well as herbal fibers, which included linen, hemp, and various species of grass. Since the Renaissance era and until 1940, there were significant changes in regards to the types of suture materials used; these changes involved the use of catgut, cotton, and surgical silk. In the 1940’s, the first synthetic suture materials – nylon and polyester – were developed; soon thereafter, polyethylene and polypropylene sutures 8 were developed. In 1970, polyglycolic acid suture was introduced; during the 1970s, polyglactine 910, an essential component of synthetic absorbable suture, became available. Classifications/Characteristics of Traditional Suture Materials and Surgical Needles In order to appreciate today’s technological advancements in sutures, specialty needles, and topical skin adhesives, it is helpful to first review the classifications and characteristics of traditional sutures and surgical needles. Sutures The three primary attributes of any suture material are its physical, handling, and tissue reaction characteristics13: • Physical characteristics. The physical characteristics of sutures can be measured or visually determined according to the following properties: ○○ Physical configuration, ie, monofilament (single-stranded) or multifilament (multistranded) which contains numerous fibers that are twisted or braided into a single thread. ○○ Capillary. This is the suture’s ability to transmit fluid along the strand. ○○ Diameter or size. Suture size is measured in millimeters and expressed in United States Pharmacopeia (USP) sizes with zeros, ie, the smaller the diameter, the more zeroes. Sizes range from #7 (largest) to 11-0 (smallest). Sutures in sizes between 0 and 4-0 are typically used in general surgery. The surgeon will select the finest suture possible for the tissue being closed. A smaller size (ie, finer diameter) suture provides better handling qualities and small knots. In addition, sutures of finer diameter facilitate improved suturing techniques. ○○ Tensile strength. This refers to the amount of weight (ie, breaking load) that is required to break a suture (ie, breaking strength). ○○ Knot strength. This is defined as the strength required to cause a given type of knot to slip, either partially or completely. ○○ Elasticity. Elasticity refers to the suture’s inherent ability to regain its original length or form after it has been stretched. ○○ Memory. This refers to the capacity of a suture to return to its previous shape after being re-formed, ie, as when tied. A high memory results in less knot security. • Handling characteristics. The handling characteristics of a suture material include pliability, how easily the material bends and coefficient of friction, or how easily a suture slides through tissue and can be tied. For example, a suture with a high coefficient of friction has a tendency to drag through tissue; it is also more difficult to tie because its knots do not set easily. Some sutures are coated to reduce their coefficient of friction; this coating improves the way the suture pulls through tissue on insertion and also reduces the force needed to remove the suture after the wound has healed. A suture’s coefficient of friction should not be too low, since the knots will be loosened too easily. • Tissue-reaction characteristics. A suture is a foreign substance in the body; therefore, all suture materials will cause some type of tissue reaction. A tissue 9 reaction begins when the tissue is injured upon insertion and continues as the tissue reacts to the suture material itself. The tissue reaction to a suture material begins with the infiltration of white blood cells into the affected area; next, macrophages and fibroblasts arrive; by approximately the seventh day, fibrous tissue with chronic inflammation is seen. This reaction will continue until the suture is either absorbed or encapsulated. Based on the body’s reaction to suture materials, ie, absorption or encapsulation, sutures are classified as either absorbable or nonabsorbable14,15: • Absorbable sutures. An absorbable surgical suture is defined as a sterile, flexible strand developed from collagen derived from healthy mammals or prepared from a synthetic polymer. It is capable of being absorbed by living mammalian tissue; it may be treated to modify its resistance to absorption; it may be modified in regards to its texture or body; it may be impregnated with a coating, softening, or antimicrobial agent; and it may be colored with a color additive that is approved by the United States Food and Drug Administration. As such, absorbable sutures vary in their texture, structure, size, and color, according to their purpose. During the healing process, absorbable sutures are either digested (through enzymatic activity) or hydrolyzed (broken down through reaction with water in the tissue fluid) and assimilated by the tissues. The various types of absorbable sutures include surgical gut (either plain or chromic) and synthetic. ○○ Surgical gut. Surgical gut (ie, catgut), highly purified collagen, is prepared from the submucosal layer of sheep intestine or the serosal layer of beef intestine; it is processed by electronically spinning and polishing the strands into various sizes. It can be remain plain, or it may be treated with a chromium salt solution, ie, chromic sutures. Plain sutures may provoke a marked foreignbody response. The chromicizing process increases the suture’s resistance to the digestive action of tissue enzymes, thus delaying absorption. In addition, chromic gut sutures result in less tissue reaction than plain gut sutures. ○○ Synthetic absorbable sutures. To manufacture synthetic absorbable sutures, specific polymers are extruded into the strands. The base material for these sutures is a combination of lactic acid and glycolic acid polymers. Synthetic absorbable sutures are prepared as either monofilament or multifilament strands. Tissue reactions with this type of suture are mild; they are further reduced when a monofilament strand is used. This type of suture is also stronger than surgical gut; the tensile strength lasts longer (after approximately seven days, 60% or more of the suture’s tensile strength remains). The suture is absorbed through hydrolysis, which is responsible for the mild tissue reaction; the suture is usually absorbed after 42 to 70 days. Polydioxanone suture is generally absorbed after 90 to 180 days. Braided polymers have similar handling characteristics to silk sutures; in addition, their higher coefficient of friction results in good knot security. Monofilament or coated sutures are smoother and slicker and therefore require additional throws for improved knot security. Poly-4-hydroxybutyrate suture is a recently FDA10 approved monofilament absorbable suture based on recombinant DNA technology. This suture is highly flexible and maneuverable, however, its use may be limited in patients who are allergic to the cells or growth medium used in its manufacture. • Nonabsorbable sutures. Nonabsorbable sutures are strands of materials that are not digested by tissue enzymes nor are they hydrolyzed by body fluids; they are considered permanent sutures. Nonabsorbable sutures are used when the suture strength must be retained for longer than a 2 to 3 week period of time; except for wire sutures, they should not be used in the presence of infection, since the suture itself could become the site of an infection, necessitating its removal. The USP outlines the three following classes of nonabsorbable sutures: ○○ Class I Suture. This class includes suture composed of silk or synthetic fibers (monofilament, with a twisted or braided construction). ○○ Class II Suture. This class includes suture composed of cotton or linen fibers or coated natural or synthetic fibers, in which the coating contributes to the thickness of the suture, but does not significantly affect its strength). ○○ Class III Suture. Suture that is composed of metal wire, either monofilament or multifilament, is included in this class. The strand of suture material may be uncoated or coated with a substance to decrease capillary and friction when it is passed through tissue. There are various products used for coatings, such as silicone, polytef, and other polymers. The fibers may be uncolored, naturally colored, or impregnated with an appropriate dye. Nonabsorbable sutures are encapsulated by the surrounding tissues during the wound healing process. They are often used to suture skin and are removed before healing is complete. The most common types of nonabsorbable sutures are16,17: ○○ Silk. In the past, surgical silk was the most commonly used nonabsorbable suture material. Silk suture is prepared from thread spun by the silkworm. After the raw silk is processed (ie, the natural waxes and gum are removed; it is manufactured into threads; and it is colored with a vegetable dye), the strands are twisted or braided to form the suture, which gives it high tensile strength and better handling qualities. Silk suture is soft, handles well, and forms secure knots. However, due to the capillary of untreated silk, body fluids may transmit infection along the length of a suture strand; for this reason, surgical silk is treated to eliminate its capillary properties and enable it to resist the absorption of moisture and body fluids, but still should not be used in an infected wound. Silk suture causes a greater degree of tissue reaction in comparison to other commonly used nonabsorbable sutures. Silk suture should be used dry, because it is weakened by moisture. Its tensile strength decreases after 90 to 120 days; the suture is generally absorbed within 2 years. Therefore, silk is not a true 11 nonabsorbable material, but is classified as such because it remains in tissue for so long. ○○ Nylon. Surgical nylon suture is made from a synthetic polyamide polymer; it is available in monofilament and multifilament (braided) forms. Monofilament nylon suture is a smooth material that is noncapillary and handles easily; however, because of its poor knot security, it does require additional throws for knot security. Multifilament nylon is relatively inert in tissue and has a high tensile strength; it is braided very tightly and treated for noncapillary. Nylon sutures handle like silk, but with less tissue reaction. Nylon suture loses 15% to 20% of its tensile strength every year in tissue and will not provide indefinite support. ○○ Polyester. Polyester suture is made from polyethylene terephthalate fibers that are available in fine filaments that are braided together into various suture sizes to provide good handling properties. Polyester suture is available in two forms: a nontreated polyester fiber suture and a polyester fiber suture that has been impregnated with polybutylate, a synthetic coating that is a surgical lubricant to facilitate smooth passage of the suture through tissue. Polybutester is a special type of polyester suture that has many of the advantages of polyester and polypropylene; because it is monofilament, it induces very little tissue reaction. Polyester suture has several advantages over other nonabsorbable, braided sutures, including that it is not absorbed in tissue fluid, has greater tensile strength, and offers maximal visibility. ○○ Polypropylene. Polypropylene suture is a polymer, which is either clear or pigmented; it allows little or no saturation. It is a smooth monofilament suture that does not weaken in tissues, is easy to handle, holds knots securely, and causes very little tissue reaction. Because it is extremely inert in tissue, polypropylene may be used in the presence of infection. ○○ Stainless steel wire. Surgical stainless steel wire sutures are made from strong, flexible, uniform steel alloy; they are designed to be compatible with stainless steel implants and prostheses; and are known for their strength, inert properties, and low tissue reaction. Stainless steel sutures are available as either monofilament or multifilament wire; both types can be held securely in place by twisting or knotting the suture. The major disadvantages of surgical stainless steel is related to handling, eg, suturing technique is very challenging, gloves can be punctured, barbs on the end of steel can traumatize surrounding tissue, and it can pull or tear out of tissue. Based on these characteristics, the surgeon selects the type of suture material that is best suited to maintain tensile strength and promote healing.18 Additional considerations in the choice of suture material include the condition and age of the patient; the presence of infection; and the type of tissue to be sutured.19 12 Surgical Needles20,21 A surgical needle transports the suture material through tissue during a procedure with as little tissue trauma as possible. Surgical needles are made from stainless steel or carbon steel; they are available in various sizes, shapes, point design, and wire diameter. Needles must be strong enough to penetrate tissue without bending, breaking or deforming; ductile; and capable of withstanding the stress imposed by tough tissues. Stainless steel is generally the most popular metal for needles because it provides these three characteristics and is noncorrosive. A new Tungsten-rhenium alloy has been applied to needle designs; this ultra-high-strength alloy provides more strength and bend resistance than conventional stainless steel needles.22 The three basic parts of a surgical needle are: • Eye. The eye of a needle is located at the end, where the suture is attached. The three types of needle eyes are closed eyed, in which the needle must be threaded with the strand of suture and thus two strands of suture must be pulled through the tissue; French eye or split, in which the suture is placed or snapped through a spring; and swaged, in which the needle is permanently attached to one or both ends of the suture material. The swaged needle is most commonly used. • Body or shaft. The body of the needle can be round, triangular, or flattened; they may also be straight or curved. The curve of a needle is described as part of an imaginary circle (ie, ¼ circle, ½ circle); as the radius of this imaginary circle increases, the size of the needle also increases. The body of a round needle gradually tapers to a point. • Point. The point of a needle is the end that first penetrates the tissue being sutured. The design of the point differs according to the type and density of the tissue to be penetrated; the three basic point designs are taper, blunt, and cutting. Taper needles, generally called “round” needles, cause minimal tissue trauma and leave a smaller hole in the tissue; they must be used on delicate tissue that they can easily penetrate (eg, kidney or bowel). A blunt needle does not have a sharp point; this type of needle essentially dissects the tissue as it is pushed through, resulting in less trauma than a conventional sharp, pointed needle. Blunt protectpoint needles are being recommended as an alternative to taper point needles to reduce the risk for exposure to bloodborne pathogens due to percutaneous injury. Other types of points available for use in various tissues include: ○○ Cutting taper – reverse cutting tip with tapered shaft. ○○ Penetrating point – a tapered body with a finely sharpened point; provides optimal penetration with less tissue trauma. ○○ Protect-point – a tapered body with a blunted point; no cutting edge. ○○ Regular cutting – triangular point with cutting edge on inner curvature. ○○ Reverse cutting – triangular point with cutting edge on outer curvature. ○○ Spatula side cutting – two cutting edges in horizontal plane. 13 The Role of Sutures in Effective Wound Healing and SSIs Before discussing today’s advanced sutures, needles, and other wound closure devices, it is important to review the role of sutures in effective wound healing and the development of SSIs. Every type of tissue, whether skin, fascia, or organ has its own specialized function as well as needs. When selecting a wound closure device, it is critical that the specific healing requirements for the type of tissue being repaired are taken into consideration. Although there are differences in tissue healing profiles and types of wound closure devices, in order to promote optimal patient outcomes, every wound closure device should provide strength and support to maintain tissue integrity; address the risk factors for infection, which can delay healing and cause excess scarring23,24; and minimize tissue trauma.25 The specific considerations in effective healing for skin and fascia, and organs are briefly outlined below. • Skin. The skin is the body’s largest organ and is vital to sustaining life. When the skin is compromised, such as through an incision, it is important to return skin to its original function and appearance. Therefore, secure skin closure is an integral step in nearly every surgical procedure. If the closure device does not provide the strength and support required by the skin tissue, the wound edges may separate, providing a potential pathway for bacterial contamination, which can lead to infection and suboptimal cosmesis.26,27 To create an environment that facilitates healing of the skin tissue, sutures should: ○○ Provide the support necessary to maintain wound-edge approximation during the critical healing period (5 to 7 days after surgery); ○○ Protect against colonization of the suture by organisms commonly associated with SSIs28,29; and ○○ Pass smoothly through skin to minimize tissue trauma. Appropriate support of the skin tissue helps maintain the integrity of the wound closure and minimize scarring, taking into consideration that: ○○ During skin approximation, it is important to prevent the formation of skin gaps and to keep skin edges everted. ○○ Uneven skin edges may have an adverse impact on cosmetic outcomes. ○○ Poor skin approximation can provide an entry point for bacteria to enter the wound, potentially leading to an infection, since for most SSIs, the source of pathogens is the endogenous flora of the patient’s skin, mucous membranes, or hollow viscera.30 ○○ Until the skin tissue regains sufficient strength, the sutures must provide the support the tissue requires to maintain its integrity. • Fascia. The fascia is a layer of specialized, avascular connective tissue that holds anatomical structures together. When the fascia damaged, it regains strength gradually; however, fascial healing is a slow process and may be delayed under certain circumstances: ○○ At 14 to 28 days, the fascia is self-supportive but still weak31,32; 14 ○○ Even at 2 months, it still has less than half its original strength33,34; ○○ Many surgical procedures are performed on patients with preexisting conditions that may delay healing35,36,37,38; ○○ Fascia heals even slower in patients with comorbidities – such as diabetes – or who are otherwise debilitated (ie patients with poor nutrition, cancer, acquired immunodeficiency syndrome [AIDS])39,40; and ○○ Healing may also be delayed by infection, a common complication in abdominal surgery.41,42,43,44 Until the fascial tissue regains sufficient strength, the sutures must provide the support the tissue needs to maintain its integrity.45,46 For these reasons, it is vital to effectively support the fascia while it is compromised in order to prevent complications such as hernias and dehiscence.47,48 By providing the fascia with the support it needs as it slowly heals, the risks for wound dehiscence and surgical site infections can be addressed and, thus, patients are given a better chance of healing without complications and returning to their daily lives as soon as possible.49,50 • Organ. Although an organ is often viewed as a single entity that performs a distinct bodily function, organs typically consist of several types of tissues. For example, the heart primarily consists of muscle tissues to pump blood, but it also contains many other types of tissues, such as the fibrous tissue in the valves and specialized cells that maintain its rhythm. Additionally, the close link between the heart and the vascular system increases the number of tissues associated with this organ. When a complicated structure such as the heart requires repair, it is essential to consider the specific needs of the tissue within the organ. As another example regarding the heart, to avoid complications during coronary artery bypass graft (CABG) procedures, the surgeon needs suture needles that are sharp enough to penetrate calcified tissue, even after multiple passes.51,52 On the other hand, while operating on diseased valve annuli, it is important to securely repair the damage, without harming the delicate valve tissue.53 The selection of wound closure device is determined by the tissue-specific healing times (see Figure 1). 15 Figure Figure 11 –– Minimum MinimumWound Woundhealing HealingTimes* Times* *Note: These minimum healing timestimes are for patients without medical complications. *Note: These minimum healing arehealthy for healthy patients without medical complications. There are both patient (ie, uncontrollable) and procedural (ie, controllable) factors that may potentially 54,55: increaseThere the riskare forboth postoperative as describedand below patient (ie,SSI, uncontrollable) procedural (ie, controllable) factors that Examples of uncontrollable the patient’s SSI, age and other characteristics may potentially increase thefactors risk forare postoperative as described below54,55: and comorbidities, such as diabetes, cigarette smoking, systemic steroid use, obesity (ie, over 20% • Examples of uncontrollable factors are the patient’s age and other characteristics of ideal body weight), poor nutritional status, remote site infections or colonization, and prior and comorbidities, such as diabetes, cigarette smoking, systemic steroid use, contamination of the wound. obesity (ie, over 20% of ideal body weight), poor nutritional status, remote site Controllable factors include endogenous bacteria; exogenous bacteria from perioperative infections or colonization, prior contamination of the wound. equipment, and personnel (especially members of and the surgical team); surgical instruments, • Controllable factors include endogenous bacteria; exogenous from tools brought to the sterile field during a procedure; the OR environmentbacteria (including the air); and personnel (especially members of the surgical team); surgical bacterialperioperative colonization of the suture. instruments, equipment, and tools brought to the sterile field during a procedure; OR environment (including the air); andsome bacterial colonization of the suture. Effective wound the closure provides an opportunity to address of these controllable factors, including bacterial colonization of the suture and entry of bacteria into the wound after surgery.56,57 Any Effective wound closure provides opportunity to address some of these foreign body, including suture material, mayanpromote inflammation at the surgical sitecontrollable and therefore factors, including bacterial colonization of the suture and entry of bacteria into the wound58 As increase the potential for SSI development after otherwise minimal levels of tissue contamination. Any foreign body, including suture material, may promote inflammation a result, after suturesurgery. is both56,57 a route and a site of infection. at the surgical siteofand therefore increase the potential for SSI development after59 While Suture as a route infection. Percutaneous sutures create a conduit for bacteria. 58 preoperative antimicrobial preparations can greatly amount of bacteria on the otherwise minimal levels ofskin tissue contamination. As areduce result,the suture is both a route and surface the skin, these products do not eliminate all of the bacteria, especially those bacteria a site ofofinfection. that •reside in the layers of the stratum corneum sutures or liningcreate the hair follicles for and pores.60 Suture aslower a route of infection. Percutaneous a conduit Figure 2bacteria. depicts 59 theWhile number of bacteriaantimicrobial remaining onskin the preparations surface of thecan skingreatly and inreduce the deeper preoperative layers before topicalofantiseptic and of immediately afterwards. the amount bacteria application on the surface the skin, these products do not eliminate all of the bacteria, especially those bacteria that reside in the lower layers of Figure 2 – Bacteria on the Skin Surface and in Deeper Layers:60Before and Immediately the stratum corneum or lining the hair follicles and pores. Figure 2 depicts the Following Antiseptic Application number of bacteria remaining on the surface of the skin and in the deeper layers before topical antiseptic application and immediately afterwards. Before Antiseptic Application Immediately following Antiseptic Application 16 that reside in the lower layers of the stratum corneum or lining the hair follicles and pores. Figure 2 depicts the number of bacteria remaining on the surface of the skin and in the de layers before topical antiseptic application and immediately afterwards. Figure 2 – Bacteria the SkinonSurface and in Deeper Before andBefore and Immediat Figure 2 on – Bacteria the Skin Surface and Layers: in Deeper Layers: Antiseptic Application ImmediatelyFollowing Following Antiseptic Application Before Antiseptic Application Immediately following Antiseptic Application Until the epidermis heals (within 24 to 48 hours after surgery), bacteria can enter the wound from the patient’s skin or the environment.61 • Suture as a site for infection. Microbial contamination of the surgical site is a prerequisite for a surgical site infection; furthermore, the risk of SSI increases with the dose of bacterial contamination and the virulence of the bacteria.62 In this regard, SSI risk can be conceptualized by the following relationship: Dose of bacterial contamination x virulence (resistance) _____________________________________________ Resistance of the host (patient) = Risk of SSI Foreign materials, such as sutures, reduce the number of bacteria required to cause an infection.63 Quantitatively, it has been shown that the typical bacterial concentration required for a surgical site infection to develop is105 microorganisms per gram of tissue; however, the dose of contaminating microorganisms required to produce an infection may be much lower when foreign material is present at the site (eg, 100 staphylococci per gram of tissue introduced by silk sutures). Percutaneous sutures create a conduit for bacteria to enter the wound. As with all foreign bodies, when sutures are implanted, they are rapidly coated with tissue protein; this creates sites for bacterial colonization, which can lead to biofilm formation (see Figure 3).64,65,66 Biofilm formation increases the difficulty in treating an infection.67 17 bodies, when sutures are implanted, they are rapidly coated with tissue protein; this creates sites for bacterial colonization, which can lead to biofilm formation (see Figure 3).64,65,66 Biofilm formation increases the difficulty in treating an infection.67 3 – Colonization of Suture by Bacteria Figure 3Figure – Colonization of Suture by Bacteria Colonization of a Suture Knot Colonization of Braided Suture important totonote thatthat thethe mostmost vulnerable time fortime bacterial colonization of a wound is ItItisis important note vulnerable for bacterial colonization ofthe 48 hours after wound closure. Until the epithelial barrier is complete (usually within 48 afirst wound is the first 48 hours after wound closure. Until the epithelial barrier is hours), wounds are dependent on the wound closure device to maintain the integrity of the complete within 48 bacterial hours), contamination. wounds are dependent wound closure 68 Bacteria inon thethe wound may delay wound and(usually also protect it from device to maintain the integrity of the wound and also protect it from bacterial healing and also result in poor cosmesis and/or hypertrophic scarring. contamination.68 Bacteria in the wound may delay healing and also result in poor TEChNOlOGY IN SUTURES, cosmesisADVANCEMENTS and/or hypertrophic scarring.TISSUE CONTROL DEVICES, SPECIALTY NEEDLES, AND TOPICAl SKIN ADhESIVES TECHNOLOGY ADVANCEMENTS IN SUTURES, CONTROL Today, technological advancements in sutures, tissue control devices,TISSUE specialty needles, and topical skin adhesives have led to the development of exciting new options to support contemporary surgical DEVICES, SPECIALTY NEEDLES, AND TOPICAL SKIN ADHESIVES techniques and that also provide distinct in clinical and economic benefitsdevices, by reducing the risk needles, for SSI. Today, technological advancements sutures, tissue control specialty Advanced antibacterial sutures, knotless tissue control devices, specialty cardiovascular needles, and and topical skin adhesives have to the development of exciting options below. to topical skin adhesives, including theirled related clinical and economic benefits. new are described support contemporary surgical techniques and that also provide distinct clinical and economic benefits by reducing the risk for SSI. Advanced antibacterial sutures, knotless tissue control devices, specialty cardiovascular needles, and topical skin adhesives, including their related clinical and economic benefits are described below. Antibacterial Sutures As noted above, suture selection provides an opportunity to address one of the known Antibacterial Sutures risk factor for SSI: bacterial colonization of the suture.69,70 As seen Figure 4, bacteria (the As noted above, suture selection provides an opportunity to address one of the known risk factor for darkened area) will grow in all areas petriFigure dish 4, except for(the a zone of inhibition on and 69,70of SSI: bacterial colonization of the suture. Asaseen bacteria darkened area) will grow in around suture. all areasan of aantibacterial petri dish except for a zone of inhibition on and around an antibacterial suture. Figure Bacterial Growth in Petri Dish: Prior to Incubation After 24 Hours Figure 44––Bacterial Growth in Petri Dish: Prior to Incubation and After 24and Hours Prior to incubation Zone of inhibition around an antibacterial suture at 24 hours Today, a range of sutures impregnated with triclosan, a broad-spectrum antibacterial agent, are available to meet the needs of skin and fascial tissue repair, as described below. 18 Antibacterial poliglecaprone 25 suture is a monofilament synthetic, absorbable suture Today, a range of sutures impregnated with triclosan, a broad-spectrum antibacterial agent, are available to meet the needs of skin and fascial tissue repair, as described Prior to incubation Zone of inhibition around an antibacterial suture at below. 24 hours • Antibacterial poliglecaprone 25 suture is a monofilament synthetic, absorbable Today, asuture range of sutures impregnated withtype triclosan, a broad-spectrum antibacterial containing triclosan. This of suture is used for subcuticular skinagent, are availableclosure, to meet because: the needs of skin and fascial tissue repair, as described below. Antibacterial poliglecaprone 25 suture is a monofilament synthetic, absorbable suture ○○ It has high initial breaking strength to maintain wound approximation during containing triclosan. This type of suture is used for subcuticular skin closure, because: the critical first few days (ie, 5 to 7 days) of skin healing.71 Compared with o It has high initial breaking strength to maintain wound approximation during the critical first other synthetic absorbable material, this suturewith hasother the highest initial 71 Compared synthetic absorbable few days (ie, 5 to 7 days) ofsuture skin healing. breaking strength to maintain wound edge approximation during those criticalwound suture material, this suture has the highest initial breaking strength to maintain first postoperatively, skinfirst needs most support (see edgedays approximation duringwhen thosethe critical daysthepostoperatively, whenFigure the skin needs 5). the most support (see Figure 5). FigureFigure 5 – Breaking Strength of Antibacterial Poliglecaprone Suture in in Postoperative 5 – Breaking Strength of Antibacterial Poliglecaprone Suture Postoperative Days Days o○○ ItIt has has been shown in vitro vitro to to kill killbacteria bacteriaand andinhibit inhibitbacterial bacterialcolonization colonizationofofthe suture. o the Thesuture. monofilament design and polymer properties minimize drag force and elicit only a 72,73,74 slightmonofilament tissue reaction duringand absorption. ○○ The design polymer properties minimize drag force and elicit only a slight tissue reaction during absorption.72,73,74 • Antibacterial polydioxanone monofilament synthetic absorbable suture is prepared from the polyester poly (p-dioxanone) and also contains triclosan. This type of suture is particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. Antibacterial polydioxanone sutures are specifically designed for secure fascial closure. As discussed above, since the fascia heals slowly, fascial closure presents unique clinical challenges, such as the risk of dehiscence and infection. However, choosing the appropriate material for fascial closure can help address known risk factors for these complications.75,76 To create an environment that facilitates healing of the fascial tissue, a suture should: 19 discussed above, since the fascia heals slowly, fascial closure presents unique clinical challenges, such as the risk of dehiscence and infection. However, choosing the appropriate material for fascial closure can help address known risk factors for these complications.75,76 To ○○ Provide that the strength supportofthe resist abdominal pressure create an environment facilitatestohealing thefascia fascialand tissue, a suture should: o Provide thethrough strengththe to critical supporthealing the fascia and(14 resist abdominal pressure through the 77,78; period to 28 days after surgery) and beyond 77,78 critical healing period (14 tocolonization 28 days after and ○○ Protect against of surgery) the suture bybeyond organisms; commonly associated 79,80 o Protect against colonization of the suture by organisms commonly associated with with SSIs ; and SSIs79,80; and ○○ Pass smoothly through fascia to minimize tissue trauma. o Pass smoothly through fascia to minimize tissue trauma. Antibacterial polydioxanone monofilament synthetic absorbable suture are specifically Antibacterial monofilament absorbable are specifically designedpolydioxanone for secure fascial closure in synthetic multiple patient typessuture because: designed for secure fascial closure in multiple patient types because: ○○ They retain 60% of its original strength for 6 weeks, providing support to the o They retain 60% of its original strength for 6 weeks, providing support to the fascia as it fascia as it slowly heals; slowly heals; ○ ○ Their monofilament polymerminimize properties minimize drag force and o Their monofilament design anddesign polymerand properties drag force and elicit only a 81 elicit only a slight tissue reaction during absorption ; and 81 slight tissue reaction during absorption ; and ○○ They shown vitro to kill and inhibit bacterial colonization o They have been have shownbeen in vitro to killinbacteria andbacteria inhibit bacterial colonization of the suture. Figure 6 shows difference in adherence of MRSA to non-triclosan treated of the suture.the Figure 6 shows the difference in adherence of MRSA to nonsutures andtriclosan suturestreated treated sutures with triclosan. and sutures treated with triclosan. Figure 6 – Difference Difference of of MRSA MRSAAdherence: Adherence:Non-Triclosan Non-TriclosanTreated TreatedSutures Sutures(left) (left)and and Triclosan Treated Sutures Sutures (right) (right) MRSA adheres to non-triclosan-treated suture (magnification 5,400 times) Only a few MRSA (arrows) adhere to triclosantreated suture (magnification 5,260 times) • Antibacterial polyglactin suture isabsorbable a syntheticsurgical absorbable surgical suture Antibacterial polyglactin 910 suture is910 a synthetic suture composed of a copolymer made from 90% glycolide and 10%from L-lactide and also contains composed of a copolymer made 90% glycolide and 10%triclosan. L-lactideThis and type also of suture also provides multipleThis benefits, including: contains triclosan. type of suture also provides multiple benefits, including: o A predictable breaking strength retention to provide for 14 to 28 for days ○○ A predictable breaking strengthprofile retention profilesupport to provide support 14while to 28 tissues healdays (seewhile Figure 7); tissues heal (see Figure 7); 20 7 – Breaking Strength of Antibacterial Polyglactin 910 Suture Figure Figure 7 – Breaking Strength of Antibacterial Polyglactin 910 Suture in in Postoperative Days Postoperative Days ○○ In vitro ability to kill bacteria and inhibit bacterial colonization of the suture; and o In vitro ability to kill bacteria and inhibit bacterial colonization of the suture; and and polymer polymer properties propertiesthat thatminimize minimizedrag dragforce forceand andelicit elicit only o○○ Suture Suture coating coating and only a slight atissue slightreaction tissue reaction during absorption. during absorption. Theuse useofofantibacterial antibacterialsutures sutures offers several distinct clinical economic benefits, The offers several distinct clinical andand economic benefits, including fewer including fewer SSIs,inwith reductions in and health care costs andofimproved quality82ofIn life forsutures vitro, SSIs, with reductions health care costs improved quality life for patients. 82 In vitro, sutureshave with antibacterial the ability to patients. with antibacterial protection demonstratedprotection the ability have to kill demonstrated bacteria and inhibit bacterial kill bacteriaofand inhibitpathogens bacterial commonly colonization of variouswith pathogens associated colonization various associated SSIs; thecommonly results of several research studies are outlined below. with SSIs; the results of several research studies are outlined below. In a study conducted by Rothenburger et al a tricolan-coated polyglactin suture was evaluated • inInvitro a study conducted by Rothenburger al a tricolan-coated polyglactin Staphylococcus for its ability to inhibit the growth ofetwild-type and methicillin-resistant suture (MRSA) was evaluated in vitro for its epidermidis. ability to inhibit theresults growthdemonstrated of wild-type that the 83 The aureus and Staphylococcus and methicillin-resistant Staphylococcus (MRSA) triclosan-coated polyglactin suture inhibitedaureus the growth of theand testStaphylococcus organisms consistently over 83 The results demonstrated the triclosan-coated polyglactin aepidermidis. range of suture diameters and treatment that conditions. The antibacterial effect was robust and did not diminish to 7 days. suture inhibitedfor theupgrowth of the test organisms consistently over a range of suture diameters and treatment conditions. The antibacterial effect was robust Edmiston et al assessed adherence and the antibacterial activity of a triclosan-coated and did not diminish for bacterial up to 7 days. polyglactin braided suture against selected Gram-positive and Gram-negative clinical isolates Staphylococcus and Escherichia in culture media. • (MRSA, Edmiston et al assessedepidermidis, bacterial adherence and thecoli) antibacterial activity84ofThe results demonstrated substantial reductions in both Gram-positive and Gram-negative a triclosan-coated polyglactin braided suture against selected Gram-positivebacterial adherence on the triclosan-coated sutures compared with noncoated suture, which was and Gram-negative clinical isolates (MRSA, Staphylococcus epidermidis, associated with decreased microbial viability. The authors concluded that, because bacterial 84 and Escherichia coli) in culture media. The results demonstrated substantial contamination of suture material within a surgical wound may increase the virulence reductions in both Gram-positive and Gram-negative bacterial adherence on the of a SSI, treating the suture with triclosan offers an effective strategy for decreasing perioperative triclosan-coated sutures compared with noncoated suture, which was associated surgical morbidity. with decreased microbial viability. The authors concluded that, because bacterial of suture material within surgical et wound may increase the of Acontamination prospective clinical study conducted byaRozzelle, al evaluated the incidence virulence of a SSI, treating the suture with triclosan offers an effective strategy for cerebrospinal fluid (CSF) shunt infections after shunt procedures using either antimicrobial decreasing perioperative surgical morbidity. 85 sutures or conventional sutures. The results of this study demonstrated that the infection rate was significantly reduced in the antimicrobial suture group (4.3%) compared to the control • group A prospective (21%). clinical study conducted by Rozzelle, et al evaluated the incidence of cerebrospinal fluid (CSF) shunt infections after shunt procedures using Ming, et al evaluated the efficacy of polydioxanone suture with and without triclosan against gram-positive and gram-negative bacteria (Staphylococcus aureus, MRSA, Staphylococcus 21 epidermidis, methicillin-resistant Staphylococcus epidermidis, Klebsiella pneumoniae, and either antimicrobial sutures or conventional sutures.85 The results of this study demonstrated that the infection rate was significantly reduced in the antimicrobial suture group (4.3%) compared to the control group (21%). • Ming, et al evaluated the efficacy of polydioxanone suture with and without triclosan against gram-positive and gram-negative bacteria (Staphylococcus aureus, MRSA, Staphylococcus epidermidis, methicillin-resistant Staphylococcus epidermidis, Klebsiella pneumoniae, and Escherichia coli) by a zone of inhibition assay.86 The results of this study demonstrated that polydioxanone suture with triclosan demonstrated activity against all test organisms in vitro; furthermore, Escherichia coli) activity by a zone inhibition until assay. The results of this study the antibacterial wasofmaintained the86sutures dissolved after 17 demonstrated t to 23 days when testedwith against Escherichia coli andactivity Staphylococcus aureus, polydioxanone suture triclosan demonstrated against all test organisms in vi respectively.the Theantibacterial results in animal models a 99.9% reduction in furthermore, activity was demonstrated maintained until the sutures dissolved after 17 Staphylococcus and a 90% reduction in Escherichia coli compared to the days when testedaureus against Escherichia coli and Staphylococcus aureus, respectively. The controls. results in animal models demonstrated a 99.9% reduction in Staphylococcus aureus and 90% reduction in Escherichia coli compared to the controls. • In regards to cost savings, Fleck, et al evaluated the use of triclosan-coated closure of the sternal notingthe that most SSIs are related sutures for t Insutures regardsfortothe cost savings, Fleck, et incision, al evaluated use of triclosan-coated 87 to the incision site. In this study, 479 patients underwent a cardiac closure of the sternal incision, noting that most SSIs are related tosurgical the incision site.87 In t procedure; of theseunderwent patients, 103 were closed with procedure; triclosan-coated suture study, 479 patients a cardiac surgical of these patients, 103 were material and the remaining 376 patients had their incision closed with noncoated with triclosan-coated suture material and the remaining 376 patients had their incision cl sutures. The results demonstrated that 24 patients (all from the conventional with noncoated sutures. The results demonstrated that 24 patients (all from the conventi suture group) had superficial or deep sternal wound infections, with an estimated suture group) had superficial or deep sternal wound infections, with an estimated cost pe cost per patient of $11,200). In the group whose incisions were closed with patient of $11,200). In the group whose incisions were closed with triclosan-coated sutur triclosan-coated suture, no wound infection or dehiscence was observed during wound infection or dehiscence was observed during their hospital stay and follow-up visi their hospital stay and follow-up visits. Knotless Tissue Knotless TissueControl ControlDevices Devices Knotless tissue technologicaladvancement advancementin in sutures and wou Knotless tissuecontrol controldevices devicesrepresent represent another another technological sutures closure devices. Thisdevices. type of device consists of aconsists uniqueofanchor design, a suture and wound closure This type of device a unique anchorwith design, with needle on enda or a surgical one and aneedle loop ononthe the abarbs allow tissue suture needleneedle on eachonend or end a surgical oneother; end and loop on thefor other; the approxim without need to tie surgical knots without (see Figure 8). to tie surgical knots (see Figure 8). barbsthe allow for tissue approximation the need Figure 8 – Knotless Tissue Control Device Figure 8 – Knotless Tissue Control Device With significantly more points of fixation (ie, anchors (or “barbs”) spaced 1 mm apart) along the s than traditional sutures, knotless tissue control devices provide surgeons with more consistent te control over every pass; they also combine the 22 strength and security of interrupted closure with m 88,89,90 With significantly more points of fixation (ie, anchors [or “barbs”] spaced 1 mm apart) along the suture than traditional sutures, knotless tissue control devices provide surgeons with more consistent tension control over every pass; they also combine the strength and security of interrupted closure with more efficiency than continuous closure.88,89,90 The unique anchor designs provide multiple points of fixation along the suture, allowing tension on the suture to be maintained during closure. Because there is no need for an assistant to follow the suture, closure is more efficient than continuous suturing with traditional sutures. Knotless tissue control devices can close wounds substantially faster than using an interrupted technique with the combination of equal strength and security.91,92,93,94 As noted above, the selection of wound closure device is determined by the tissuespecific healing times. Knotless tissue control devices are available in short-term, longterm, and nonabsorbable polymers in various sizes and lengths, with multiple needle types, to address the needs of multiple procedures, including open, laparoscopic, and robotic and also to provide the appropriate support for wound closure, including95: • Spiral PGA-PCL knotless tissue control device. This is a synthetic absorbable monofilament suture, with a surgical needle on each end, prepared from a copolymer of glycolide and e-caprolactone. It provides strength and support to maintain tension for 1 to 2 weeks and absorbs in 90 to 120 days. • Spiral PDO (dyed polyester, poly [p-dioxanone]) knotless tissue control device also has a surgical needle on each end. It provides strength and support to maintain tension for 4 to 6 weeks and absorbs in 120 to 180 days. • Spiral polypropylene knotless tissue control device. This type of device has a surgical needle on one end and a loop at the opposite end; it is designed to anchor with the closed loop at one end and the unidirectional barbed section on the other end. It provides permanent strength and support to maintain tension. The clinical and economic benefits of knotless tissue control devices across multiple surgical specialties have also been reported in the literature, as outlined below. • Eickmann and Quane conducted a retrospective data review of 178 patients who had total knee arthroplasty procedures.96 For 88 of these procedures, conventional absorbable sutures were used for interrupted closure of the retinacular and subcutaneous layers and for running closure of the subcuticular layer; for 90 procedures, bidirectional barbed absorbable sutures were used for running closure of the retinacular and subcutaneous layers. The results demonstrated that the procedures performed with the barbed sutures were significantly faster than those performed with conventional sutures (average times of 74.3 minutes and 85.8 minutes, respectively) with no adverse clinical effects. • Einarsson et al conducted a retrospective analysis of 138 consecutive laparoscopic myomectomies to compare perioperative outcomes using a bidirectional barbed suture versus conventional smooth suture.97 The results demonstrated that the use of bidirectional barbed suture significantly shorten the average length of the procedure (118 minutes in this group versus 162 minutes 23 in the conventional suture group) and reduced the length of hospital stay (0.58 days versus 0.97 days). There were no significant differences observed between the two groups in regards to incidence of perioperative complications, estimated blood loss, and number or weight of myomas removed during surgery. The authors concluded that the use of bidirectional barbed suture seemed to facilitate closure of the hysterotomy site in laparoscopic myomectomy. • Warner and Gutkowski evaluated a progressive tension suture technique modification using a barbed suture to plicate the abdominoplasty flap to the underlying abdominal wall to determine if the benefits of this technique can be achieved in a shorter operating time.98 The placement of the suture was performed with a running suture technique to provide progressive tension, which results in minimal tension along the incision line. Data from 58 patients undergoing abdominoplasty using this technique were examined, including time to insert the sutures and complications such as seroma, hematoma, and skin necrosis. The results demonstrated a marked decrease in the time necessary to perform the modified progressive tension suture technique using barbed sutures compared to previously published data. The authors’ average time was nine minutes to complete plication of the entire abdominal flap. They concluded that the use of barbed sutures to perform progressive tension suture closure in abdominoplasty is a safe and effective method to substantially decrease operating time while retaining all the benefits of the original progressive tension suture technique. Specialty Cardiovascular (CV) Needles Ongoing technological advancements have also lead to the development of an innovative specialty needle developed from a tungsten-rhenium alloy and novel coating for use in CV procedures (see Figure 9). Figure 9 – Specialty Cardiovascular Needle 24 This type of needle incorporates the latest technological advances in CV needle technology with the same polypropylene sutures that have been used for over 40 years; moreover, polypropylene suture has99: • Been used in over 100 million people worldwide and in 8 out of 10 CABG procedures; • High tensile strength and “stretch before break” breaking resistance engineered into every strand; and • Uniform suture diameter, which avoids weak spots. Patients undergoing CABG procedures are typically older with comorbidities; as a result, surgeons may encounter challenging situations during surgery, such as calcified and friable vessels.100,101,102 To avoid complications in these challenging situations, needles should be: • Stronger and more bend resistant for more precise needle placement, since encountering calcified vessels can bend, break, or dull standard stainless steel needles.103 • Sharp enough to penetrate calcified tissue, even after multiple passes, since needle dulling can increase the penetration force required and cause tenting and tissue trauma, which may slow healing of the vessel anastomoses.104,105 • Smaller and thinner to minimize tissue trauma and bleeding in small, friable vessels.106 A specialty CV needle is designed to meet these challenges, thereby providing several key clinical benefits for today’s cardiovascular interventions, such as: • Increased strength and bend resistance. Current stainless steel alloys cannot be strengthened without sacrificing the ductility of the needle. Therefore, an ultra-high-strength tungsten-rhenium alloy makes this type of needle up to 38% stronger and 121% more bend resistant than conventional stainless steel suture needles, without compromising ductility.107,108 • Maximum penetration consistency. A unique multilayer silicon coating facilitates superior penetration and also helps to maintain the durability of the tip over multiple passes and also through unexpected calcium deposits.109 • Easier handling and arming in various positions due to advanced needle geometry and non-magnetic properties.110 Topical Skin Adhesives Technological advancements in wound closure devices have also led to the development of innovative topical skin adhesives. As discussed, secure skin closure is an integral step of nearly every surgical procedure; moreover, if the closure device does not provide the strength and support required by the skin tissue, the wound edges may separate, providing a potential pathway for bacterial contamination, which can lead to infection, suboptimal cosmesis, and decreased patient satisfaction.111,112 Today, an advanced topical skin adhesive formulation, used to hold the approximated skin edges of a surgical incision wound closed, has been shown to provide excellent 25 strength and microbial protection versus other topical skin adhesives.113 This formulation consists of: • A highly purified 2-octylcyanoacrylate monomer, which, after polymerization is stronger, more flexible, and less brittle than other cyanoacrylates.114 • A chemical initiator in the applicator tip to ensure consistent, reliable polymerization times.115 A highly purified 2-octylcyanoacrylate monomer, after polymerization is116 stronger, more • Additives to enhance strength, flexibility,which, and adherence to the skin. flexible, and less brittle than other cyanoacrylates.114 AThis chemical in the helps applicator tip to ensureby consistent, reliable polymerization uniqueinitiator formulation protect patients maintaining wound integrity.117,118times. The 115 116 Additives to enhance and adherence to the plasticizers increase strength, flexibility flexibility, and 3-dimensional strength forskin. secure wound closure and improved patient comfort; an initiator enables consistent setting time across varying This unique formulation protect 119 patients by maintaining wound integrity.117,118 The plasticizers conditions and helps skin types. increase flexibility and 3-dimensional strength for secure wound closure and improved patient comfort; 119 excellent an initiator enables consistent time across varyingclinical conditions and skin types. Advanced topical skinsetting adhesives offer several benefits; in this regard, Advanced topical skin offerwith several clinical benefits; in this regard, outcomes can outcomes canadhesives be achieved the use of an advanced topical skinexcellent adhesive: be achieved •withProvides the use oftheanstrength advanced skin adhesive: to topical maintain skin edges so that they remain approximated Providesand thelevel. strength to maintain edges that they remain approximated and level. When used in skin addition to so suture, an advanced topical skin adhesive When used in addition to suture, an advanced topical skin adhesive has been shown ex vivo to has been shown ex vivo to add 75% more strength 120 to wound closure than sutures add 75%alone. more120strength to wound closure than sutures alone. • Distributes tension entire adding incision, addingstrength uniformtostrength to the Distributes tension along thealong entirethe incision, uniform the incision and incision and preventing the formation skin when the skin is stressed. preventing the formation of skin gaps when the of skin is gaps stressed. Figure 10 shows the Figure 10 shows the difference between closed with sutures difference between an incision closed with suturesan andincision one closed with sutures andand an one closed with and an topical adhesive. The figure shows (on advanced topical skinsutures adhesive. Theadvanced figure shows thatskin in the incision closed with sutures the incision left), closed skin gaps at aand force the left),that skiningaps form at aclosed force ofwith 182sutures mmHg;(on thethe incision withform sutures an advanced skin (on the right)with maintains a force of 320 of topical 182 mm Hg;adhesive the incision closed suturesskin andapproximation an advanced at topical skin mm Hg.121 adhesive (on the right) maintains skin approximation at a force of 320 mm Hg.121 Figure Incision Closed with Sutures andand an an Figure10 10––Incision IncisionClosed Closedwith withSutures Sutures(left); (left); Incision Closed with Sutures 122 122 Advanced AdvancedTopical TopicalSkin SkinAdhesive Adhesive(right) (right) Creates a strong,aflexible preventtobacteria entering incisionthe until the • Creates strong,barrier flexibletobarrier preventfrom bacteria fromthe entering incision epidermis hasthe fully healed. Providing an effective microbial barrier is microbial a key factor in preventing until epidermis has fully healed. Providing an effective barrier is SSIs. In avitro have demonstrated thatexperiments octylcyanoacrylate tissue adhesive keyexperiments factor in preventing SSIs. In vitro have demonstrated thatprovides a barrieroctylcyanoacrylate to microbial penetration many of provides the organisms (eg,to Staphylococcus epidermidis, tissuebyadhesive a barrier microbial penetration by Staphylococcus aureus, Escherichia coli, Enterococcus faecium, Pseudomonas aeruginosa) many the with organisms (eg, Staphylococcus epidermidis, Staphylococcus aureus, 123,124 responsible forofSSIs 95% confidence of 99% efficacy for 72 hours. Inhibits bacterial growth. Adhesive topical skin26adhesives have also demonstrated in vitro Escherichia coli, Enterococcus faecium, Pseudomonas aeruginosa) responsible for SSIs with 95% confidence of 99% efficacy for 72 hours.123,124 • Inhibits bacterial growth. Adhesive topical skin adhesives have also demonstrated in vitro inhibition of gram-positive bacteria (eg, MRSA and MRSE) and gramTable 1 – Percent Inoculum negative bacteria Inhibition (Escherichia in coli), as outlinedCount in Tableafter 1.125 10 Minutes of Contact T Advanced Topical Skin Adhesive126 Table 1 – Percent Inhibition in Inoculum Count after 10 Minutes of Contact Time with Advanced Topical Skin Adhesive126 Organism MRSA Organism MRSE MRSA Escherichia MRSE coli Escherichia coli Percent Inhibition 99.999 Percent Inhibition 99.999 99.99 99.99 99.99 99.99 The use of advanced topical skin adhesives for effective wound closure also offers severa Theinuse of advanced topical skin for effective wound closure also offers benefits regards to reducing the adhesives risk for SSIs. several economic benefits in regards to reducing the risk for SSIs. A retrospective analysis of over 155,000 Cesarean section procedures compared • A retrospective analysis of over 155,000 Cesarean section procedures postoperative clinical and economic outcomes using a topical compared the postoperative clinical and economic outcomes using a skin topicaladhesive (2-oc cyanoacrylate) versus conventional skin closure methods (suture, staples, topical skin adhesive (2-octyl cyanoacrylate) versus conventional skin closure methods adhesive, staples plus skin women (suture,and staples, topical skintopical adhesive, andadhesive) staples plusintopical skinundergoing adhesive) total abdo 127 127 The results in women undergoing total abdominal hysterectomy. The results thispatients study in whom of this study demonstrated thatofthe hysterectomy. demonstrated that the patients whom an advanced topical skin adhesive was on averag topical skin adhesive was usedinhad lower hospitalization costs by $500 used had lower hospitalization costs by $500 on average and decreased use decreased use of nonprophylactic antibiotic after Day 4 compared to of patients clos nonprophylactic antibiotic after Day 4 compared to patients closed with sutures or sutures or staples (see Figure 11). staples (see Figure 11). Figure 11 –11 Total Hospitalization Costs of Costs Cesarean Patients Closed with Figure – Total Hospitalization ofSection Cesarean Section Patients Closed Sutures, Staples, and Topical Skin Adhesive Sutures, Staples, and Topical Skin Adhesive This authors of this study concluded 27 that 2-octyl cyanoacrylate appears to be a sa This authors of this study concluded that 2-octyl cyanoacrylate appears to be a safe and cost-effective alternative to topical sutures, as in this study there were less favorable outcomes in the patients who received staples for wound closure. • Because of its performance as a microbial barrier to exogenous bacteria, a retrospective study of 1,300 CABG patients, assessed the effectiveness of 2-octyl cyanoacrylate used as an add-on measure in the closure of sternotomy incision wounds by comparing postoperative infection rates and length of hospital stays before and after this change in procedure.128 For the control group (ie, without the topical skin adhesive) the infection rate was 4.9%; this rate was reduced to 2.1% after the systematic use of the topical skin adhesive. Superficial and deep infection rates decreased from 4.3% and 0.6% to 2.1% and 0%, respectively. The lengths of postoperative hospital stay were also significantly reduced, decreasing from a median of 13 days to 9 days (see Figure 12). Figure 12 – Length of Stay (Days) in CABG Patients with Sternotomy Incision Wounds Closed Without and With a Topical Skin Adhesive The microbial barrier effectiveness of topical skin adhesives in reducing the risk for SSI across multiple surgical specialties has also been documented in the literature, as outlined below. • An assessment of the overall results and safety of cyanoacrylate glue applied after the surgical wound had been closed with subcuticular vicryl suture in patients undergoing primary total hip replacement demonstrated that this technique provided an immediate water tight seal in a sterile operative environment and thus provides a barrier to microorganisms; it provides good tensile strength, aesthetic value, as well as patient satisfaction.129 28 • A medical record review of 200 patients undergoing anterior cervical discectomy, microlumbar discectomy, or lumbar laminectomy demonstrated that 2-octyl cyanoacrylate is safe to use in neurosurgery patients undergoing these types of procedures, with only 1 patient in 200 having a proven infection.130 In addition, patients are able to shower and do not have sutures or staples to remove; therefore, patient responses are overwhelmingly positive. • The results of a review of children undergoing their first shunt insertion, for whom wound closure in one group was performed with an octyl cyanoacrylate tissue adhesive used for the final layer closure of the skin, demonstrated that with the use of the tissue adhesive, the wound dehiscence rate was reduced from 24% to 2% and the infection rate was reduced from 17% to 0%.131 The authors of this study concluded that this minimal change in surgical technique substantially affects the shunt infection rate due to the elimination of the “wick-effect” along filaments used to close the skin; furthermore, the adhesive itself has a bactericidal effect. SUMMARY One of the expected outcomes for every surgical patient is that he/she is free from the signs and symptoms of infection. The development of an SSI results in unnecessary discomfort, increased lengths of stay, and additional health care costs. Today, federal initiatives outlined in the ACA increase the economic pressures on health care facilities and personnel and thus incentivize them to develop and implement appropriate infection prevention strategies. In regards to wound closure devices, any foreign body, including suture material, may promote inflammation at the surgical site, thereby increasing the potential for development of a surgical site infection. Effective wound closure provides an opportunity to address known risk factors for SSI: bacterial colonization of the suture and entry of bacteria into the wound after surgery. Technological advancements in antimicrobial sutures, knotless tissue control devices, specialty CV needles, and topical skin adhesives have resulted in exciting new options to support contemporary surgical techniques and also offer distinct clinical and economic benefits to help perioperative personnel meet their infection prevention goals. Through knowledge and effective use of today’s advanced wound closure devices, perioperative personnel can realize both clinical and economic benefits by protecting surgical wounds from bacterial contamination, creating a healing environment that fosters optimal cosmesis, increasing patient satisfaction, and reducing lengths of hospital stay as well as health care costs. 29 GLOSSARY Absorbable Suture A sterile, flexible strand developed from collagen derived from healthy mammals or prepared from a synthetic polymer; it is capable of being absorbed by living mammalian tissue and may be treated to modify its resistance to absorption, modified in its texture or body, impregnated with a coating, softening, or antimicrobial agent, and colored with a color additive that is approved by the U.S. Food and Drug Administration. Biofilm A thin coating that contains biologically active organisms, capable of growing in vivo, that coat the surface of structures (eg, implanted or indwelling devices); it contains both viable and nonviable microorganisms that adhere to the surfaces and become trapped within a matrix of organic matter (eg, proteins and carbohydrates) which prevents antimicrobial agents from reaching the cells. Capillary A suture’s ability to transmit fluid along the strand. Cyanoacrylate The generic name for cyanoacrylate-based fastacting adhesives such as methyl-2-cyanoacrylate, ethyl 2-cyanoacrylate, and n-butyl-cyanoacrylate. 2-octyl cyanoacrylate is medical-grade glue, which was developed to be non-toxic and less irritating to skin tissue. Ductile In regards to metal, capable of being bent or pulled into various shapes. Elasticity A suture’s inherent ability to regain its original length or form after it has been stretched. Endogenous A source from the patient (eg, skin); caused by factors within the body or arising from internal structural or functional causes. Exogenous From a source other than the patient (eg, the environment, personnel, equipment). 30 Knot Strength The strength required to cause a given type of knot to slip, either partially or completely. Memory The capacity of a suture to return to its previous shape after being re-formed, ie, as when tied; a high memory results in less knot security. Microbial Barrier An attribute that prevents the ingress of microorganisms. Microorganism An organism that is too small to be seen with the naked eye and requires a microscope. Bacteria, viruses, fungi, and protozoa are generally called microorganisms. Monofilament Single stranded suture material. Nonabsorbable Suture Suture materials that are not digested by tissue enzymes nor are they hydrolyzed by body fluids; they are considered permanent sutures. Pathogen A microorganism that causes disease. Skin The outer protective covering of the body; it is composed of the outer epidermis and inner epidermis, containing hair, sweat glands, nerve endings, and capillaries. Surgical Site Infection (SSI) An infection at the site of a surgical incision; the infection may be superficial, deep, or it may extend to organs. Surgical Site Infection Risk Measure of the likelihood that a patient will develop an SSI. Tensile Strength Resistance to a pulling force; it refers to the amount of weight (ie, breaking load) that is required to break a suture (ie, breaking strength). Ultifilament Multistranded suture material. 31 REFERENCES 1. Petersen C. Infection. In: Perioperative Nursing Data Set: The Perioperative Nursing Vocabulary, 3rd ed, Denver, CO: AORN, Inc.; 2011:254. 2. CDC. Surgical site infection (SSI) event. January 2014. http://www.cdc.gov/nhsn/ pdfs/pscmanual/9pscssicurrent.pdf. Accessed January 15, 2014. 3. CDC. Surgical site infection (SSI) event. 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