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Study finds combination topical skin adhesive and self-adhering mesh preferred over skin staples for wound closure.
September 26, 2018
By: Johnson & Johnson
Total knee replacement patients and their surgeons were more satisfied with the cosmetic results and less worried about after care and possible infections when the DERMABOND PRINEO Skin Closure System was used to close the knee’s surgical incision rather than traditional skin staples, according to a new quantitative research study conducted by Ethicon,* part of the Johnson & Johnson Medical Devices Companies,** the manufacturer of the novel skin closure device that combines a topical skin adhesive with a self-adhering patch.1 As a replacement for sutures or staples, the DERMABOND PRINEO System provides minimally invasive closure—no holes in the skin; no sutures or staples to remove, and no dressing changes, which may potentially reduce follow-up visits and support good cosmetic results for patients.2 The DERMABOND PRINEO System has been used to close the surgical incisions of more than 1 million patients. The double-blinded quantitative study (90 percent CI) of 88 total knee replacement patients and 83 orthopaedic surgeons, found more patients had overall greater satisfaction with the proven DERMABOND PRINEO System (88.2 percent vs. 81.8 percent) and were happier with the appearance of their skin incision (80 percent vs. 71 percent). Fewer patients were worried about post-operative care (55 percent vs. 63 percent) or concerned about complications (56 percent vs. 60 percent) when the DERMABOND PRINEO System was used. Orthopedic surgeons were more satisfied with the DERMABOND PRINEO System too, but by even wider margins than their patients. Overall surgeon satisfaction was 83.7 percent compared to 56.1 percent for skin staples. Surgeons felt the System led to greater overall patient satisfaction (84 percent vs. 45 percent), better cosmetic results (88 percent vs. 40 percent) and better overall healing of the knee incision (82 percent vs. 52 percent). Surgeons were also less worried about surgical site infections (77 percent vs. 52 percent). “I like DERMABOND PRINEO because I think it creates a water tight skin closure of the arthrotomy, which is important for addressing some of the risk factors for surgical site infections and is also nice for the patient,” said Dr. Ryan Nunley,***associate professor of Orthopaedic Surgery at Washington University, St. Louis Mo., and orthopedic surgeon at Barnes Jewish Hospital. “With PRINEO, the patient may start showering soon after the procedure and feel like a normal person again, and mentally I think this helps them achieve a faster recovery period. We don’t see the train track appearance of staples and don’t need to have home nurses come to the house to remove staples or do wound management, so there is the convenience factor as well, and this is also a cost savings by eliminating the home nursing visits or additional office visits as we enter into the world of bundled payments for total joint.” The new research adds to a growing body of evidence showing the value of the DERMABOND PRINEO System in orthopaedic surgery. Recently, two economic analyses demonstrated that its use may be associated with improved patient outcomes and lower healthcare costs for hospitals.3,4 Both studies were presented at the International Society for Pharmacoeconomics and Outcomes Research’s 22nd Annual International Meeting in 2017. Building on a legacy of 20 years in topical skin adhesives, Ethicon offers a portfolio of skin closure systems for a wide variety of incision lengths and closure strength needs, including DERMABOND PRINEO Skin Closure system (42cm)—a new configuration for longer incisions to address growing customer needs in hip, knee and spine surgery. The DERMABOND family of products are the only skin closure devices backed by an extensive body of evidence, including 5,718 patients across 51 Randomized Controlled Trials (RCTs).**** The Johnson & Johnson Medical Devices Companies** have been working to make surgery better for more than a century. With substantial breadth and depth in surgical and orthopedic technologies and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services. From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years. Through Ethicon’s surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and its commitment to treat serious medical conditions like obesity and cancer worldwide, the company delivers innovation to make a life-changing impact. *Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates. Ethicon, LLC is the legal manufacturer of DERMABOND PRINEO and STRATAFIX Knotless Tissue Control Devices. All other trademarks are the property of their respective owners. **The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopedics, interventional and specialty solutions businesses within Johnson & Johnson’s Medical Devices segment. ***Dr. Ryan Nunley is a paid consultant for Ethicon. ****Based on published literature in PubMed and SCOPUS, using only RCTs that evaluated the use of the product in a manner consistent with intended indication. References 1. Double-blinded quantitative research study comparing surgeon experience with DERMABOND PRINEO System (22 cm) and skin staples in total knee arthroplasty. N=83 Orthopaedic surgeons. 90% CI. Fielded June/July 2017. 2. Ethicon Inc. DERMABOND PRINEO Skin Closure System (22cm) Instructions for Use. LAB100114233v2. 5/15 3. Johnston S, Sutton N. Comparison of Economic and Clinical Outcomes between the Dermabond® Prineo® Skin Closure System and Skin Staples in Patients Undergoing Knee Replacement in Real World Clinical Practice. Poster Presented at: ISPOR 22nd Annual International Meeting; May 20-24, 2017; Boston, MA. 4. Sadik, K, Flener J, Gargiulo J, Graves M, Nunley, R Post, Z, Wurzelbacher, Sutton, N, Hogan, Hollman, S, Ferko, N. A U.S. Hospital Budget Impact Analysis of a Skin Closure System Compared with Standard of Care in Hip and Knee Arthroplasty. Poster Presented at: ISPOR 22nd Annual International Meeting; May 20-24, 2017; Boston, MA.
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