Surgical Dressing Study Comparing SYLKE vs Other Common Incisional Dressings Following Abdominoplasty/Panniculectomy Patients

Hypertrophic Surgical Scar, Medical Adhesive Related Skin Injury

sylke, scarring, plastic surgery, abdominoplasty, panniculectomy, incisional dressing

Include primary, secondary, and exploratory objectives. Primary Goal: To compare the effects of a silk fibroin-based dressing versus standard postoperative dressings on scar quality. Secondary Goal: To compare the incidence of medical adhesive-related skin injuries (MARSIs) in the immediate postoperative period between patients treated with silk fibroin-based dressings and those treated with standard postoperative dressings, and to evaluate long-term wound healing outcomes between groups.

Include background and rationale for initiating the study. Includes pre-clinical and clinical data, current experiences with procedures, drug, or device, and any other relevant information to justify the research. This study will investigate how the use of SYLKE, a natural silk fibroin dressing, affects wound healing, scar formation, and patient outcomes compared with standard wound dressing products. Following surgical procedures, wound closure is typically achieved with sutures or staples, followed by adhesive wound dressing to cover the closed incision. Adhesive wound dressings support wound healing by absorbing exudate, providing physical protection, and promoting an optimal healing environment. Despite their widespread use, medical adhesive related skin injuries (MARSIs) caused by adhesive dressings remain a common and clinically significant problem affecting patients. MARSIs may lead to complications like delayed healing, contact dermatitis, wound enlargement, wound dehiscence, wound drainage, and worsened scar outcome. MARSI's also disrupt the skin barrier integrity, which increases patient risk for surgical site infections (SSIs). Existing studies indicate that the use of standard adhesive dressings do not consistently prevent MARSIs and SSIs or improve scar outcomes. One emerging alternative to standard adhesive dressings are silk-derived adhesives. SYLKE is an FDA approved hypoallergenic silk fibroin mesh that incorporates a pressure-sensitive acrylic adhesive. Silk fibroin exhibits minimal immunogenic response, promotes hemostasis, is permeable to water vapor, resistant to microbial colonization, and exhibits strong tensile strength. Currently, research on the impact of using silk-derived adhesive dressings is limited. Existing evidence suggests that silk-derived adhesive dressings may reduce complications caused by MARSIs and improve patient-reported outcomes; however, their impact on long-term scar quality has not been well studied. In this randomized clinical trial, our primary outcome will be scar quality after treatment with SYLKE versus standard adhesive dressings used at our institution-Dermabond Prineo and paper tape-in patients undergoing abdominoplasty or panniculectomy. We will follow patients out to 12 months and utilize a split-wound, within-patient design, to allow for side-by-side comparisons in the same individual. This study will investigate how the use of SYLKE, a natural silk fibroin dressing, affects wound healing, scar formation, and patient outcomes compared with standard wound dressing products. Following surgical procedures, wound closure is typically achieved with sutures or staples, followed by adhesive wound dressing to cover the closed incision. Adhesive wound dressings support wound healing by absorbing exudate, providing physical protection, and promoting an optimal healing environment. Despite their widespread use, medical adhesive related skin injuries (MARSIs) caused by adhesive dressings remain a common and clinically significant problem affecting patients. MARSIs may lead to complications like delayed healing, contact dermatitis, wound enlargement, wound dehiscence, wound drainage, and worsened scar outcome. MARSI's also disrupt the skin barrier integrity, which increases patient risk for surgical site infections (SSIs). Existing studies indicate that the use of standard adhesive dressings do not consistently prevent MARSIs and SSIs or improve scar outcomes. One emerging alternative to standard adhesive dressings are silk-derived adhesives. SYLKE is an FDA approved hypoallergenic silk fibroin mesh that incorporates a pressure-sensitive acrylic adhesive. Silk fibroin exhibits minimal immunogenic response, promotes hemostasis, is permeable to water vapor, resistant to microbial colonization, and exhibits strong tensile strength. Currently, research on the impact of using silk-derived adhesive dressings is limited. Existing evidence suggests that silk-derived adhesive dressings may reduce complications caused by MARSIs and improve patient-reported outcomes; however, their impact on long-term scar quality has not been well studied. In this randomized clinical trial, our primary outcome will be scar quality after treatment with SYLKE versus standard adhesive dressings used at our institution-Dermabond Prineo and paper tape-in patients undergoing abdominoplasty or panniculectomy. We will follow patients out to 12 months and utilize a split-wound, within-patient design, to allow for side-by-side comparisons in the same individual. At our institution, patients undergoing abdominoplasty or panniculectomy may undergo one of two incision patterns: the fleur-de-lis incision or the traditional transverse incision. A fleur-de-lis incision consists of a vertical midline component in addition to the traditional hip-to-hip transverse incision. In patients with a traditional transverse incision, one half of the incision will be randomized to receive SYLKE and the other half to receive a standard dressing (Dermabond Prineo or paper tape). In patients with a fleur-de-lis incision, the vertical and transverse components will be independently randomized to receive either SYLKE or a standard dressing (Dermabond Prineo or paper tape). Randomization will be performed preoperatively using a coin-flipping application. Wound healing will be evaluated at 7 days, 14 days, 1 month, 3 months, 6 months, and 12 months after surgery by a board-certified plastic surgeon, as coincides with normal post-operative care. A board-certified plastic surgeon will assess scars via photographs by Patient and Observer Scar Assessment Scale (POSAS), a validated tool for evaluating scar appearance and overall scar formation, which has been studied in analyzing photographs. Scar assessment by a board-certified plastic surgeon will occur at 1 month, 3 months, 6 months, and 12 months after surgery. Additionally, patients will independently assess their own scars at 1 month, 3 months, 6 months, and 12 months postoperatively using the POSAS. MARSIs, SSIs, and adverse events will be assessed at 7 days, 14 days, 1 month, 3 months, 6 months, and 12 months. Our hypothesis is that the incisions that are treated with the silk fibroin-based adhesive dressing will have lower rates of MARSIs and SSIs and will have higher scar quality scores compared to incisions treated with standard adhesive dressing.

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United States