Spring 2013 Volume 1/Number 1 An Incisive Surgical Publication Dear Clinician, Welcome to the inaugural issue of CLOSING COMMENTS, a periodic clinical newsletter from Incisive Surgical, the developer of the revolutionary INSORB® Absorbable Skin Stapler. The goal of the newsletter is to present valuable information to leading edge clinicians regarding the latest findings involving skin closure modalities. We encourage you to review the content of CLOSING COMMENTS, and forward any comments or insights you would like to share. Good health to all! Incisive Surgical We are extremely pleased to announce the sale of our one millionth INSORB® Absorbable Skin Stapler – approaching 30,000,000 INSORB Staples – on February 19, 2013. This is a significant milestone for our company and a testament to the profound benefits of our revolutionary surgical modality for patients, clinicians and providers. New Peer Review Study The Influence of Absorbable Subcuticular Staples, Continuous Subcuticular Absorbable Suture, and Percutaneous Metal Skin Staples on Infection in Contaminated Wounds A Pineros-Fernandez, LS Salopek, PR Rodeheaver, GT Rodeheaver, Journal of the Long-Term Effects of Medical Implants, University of Virginia Health Systems, December 2012 Methods: Full-thickness skin wounds on the abdomen of six pigs were contaminated with S. aureus and closed with one of four devices: INSORB Absorbable Staples, percutaneous metal staples, VICRYLTM Suture and MONOCRYLTM Suture. Wound infection was assessed 7 days after closure by clinical signs and quantitative bacterial swabs. Conclusion: “Following closure with subcuticular staples, the wounds demonstrated less infection, less inflammation, and acceptable cosmesis compared to subcuticular suture closure. …percutaneous staples cause peri-wound injury and inflammation, can be uncomfortable, and require removal that can be painful. These results suggest that subcuticular absorbable staples may be a superior alternative for the closure of skin incisions.” At analysis on Day 7, wounds closed with INSORB Staples demonstrated continued edge eversion, minimal inflammation, and uniform incision line healing. At analysis on Day 7, all wounds closed with VICRYL (V) or MONOCRYL (M) sutures contained purulent exudate. At analysis on Day 7, wounds closed with metal staples exhibited classic railroad tracks before and after staple removal, from the compression and inflammation at the points of skin puncture. If you want the most recent issue of CLOSING COMMENTS delivered straight to your inbox, view previous issues, or make a comment, please go to www.insorb.com/closing_comments Peer Review Study Finds Decreased Pain Results in Lower Costs & ‘Happier’ Patients Skin Closure With Subcuticular Absorbable Staples After Cesarean Section Is Associated With Decreased Analgesic Use J Nitsche, T Howell, Archives of Gynecology & Obstetrics, The MAYO Clinic and District One Hospital, October 2011 Methods: Retrospective cohort study of 95 cesarean patients closed with metal skin staples and 89 patients closed with INSORB absorbable staples. Patients in the cohort groups were all treated by the same physician in the same setting and analgesic use conformed to the institution’s post operative analgesic protocol, according to which patients received intravenous ketorolac, oral ibuprofen, and oral hydrocodone/acetaminophen. Demographic data and inhospital post-operative analgesic use were compared between the groups. Key Findings: “Our results suggest that the use of subcuticular absorbable staples for skin closure at the time of cesarean section may lead to less in-hospital analgesic use, and positively impact a patient’s post-operative course.…the decreased use of [average of 83 mg less IV administered Toradol] associated with absorbable staples would result in a cost savings of approximately $200 per patient even after considering the higher cost of the absorbable stapler.” INSORB Absorbable Subcuticular Staples Percutaneous Metal Skin Staples At Surgery (midline incision) INSORB Absorbable Subcuticular Staples Percutaneous Metal Skin Staples At 1 Week (midline incision) A study recently published in the Journal of the American College of Obstetricians & Gynecologists cites significantly greater wound complications with percutaneous metal skin staples compared to subcuticular suturing. The article titled, “Surgical [Percutaneous Metal] Staples Compared With Subcuticular Suture for Skin Closure After Cesarean Delivery: A Randomized Controlled Trial”, reviews the findings of a prospective randomized 398 patient study at the University of Alabama at Birmingham (Fiquera, et al., January 2103). KEY FINDING: Although subcuticular suture closures increased operative/anesthesia times by 10 minutes, percutaneous metal skin staples present a 14X greater risk of wound morbidity at discharge compared to suture closure. REMINDER: The proprietary INSORB Skin Closure Technology utilizes 2 surgically-sharp needles to capture a precise bilateral ‘bite’ of dermis and to deliver the INSORB Absorbable Staple into the tissue. ANY contact with a forceps, previously placed staple or other object WILL cause damage to the needles. If ANY damage is suspected, or if the device is not operating smoothly, discard and replace the device. For additional clinical information, please contact your Incisive Surgical Sales Representative, or Incisive Surgical at 1-8662INSORB. Or, visit the insorb.com website. Closing Comments is an Incisive Surgical Newsletter © 2013 Incisive Surgical, Inc.
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