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Surgical Dressing Study Comparing SYLKE vs Other Common Incisional Dressings Following Abdominoplasty/Panniculectomy Patients
Sponsor: University of Missouri-Columbia
Summary
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.
Official title: A Randomized Split-Wound Clinical Trial Comparing SYLKE Silk Fibroin Dressing to Standard Adhesive Dressings in Abdominoplasty and Panniculectomy Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-11-01
Completion Date
2028-03-01
Last Updated
2026-10-16
Healthy Volunteers
Yes
Interventions
SYLKE
This randomized clinical trial will compare the performance of SYLKE, Dermabond Prineo, and paper tape in patients undergoing abdominoplasty or panniculectomy. For each patient, incision limbs - left vs. right for transverse incision and vertical vs. transverse for fleur-de-lis incision - will be randomized to receive either SYLKE or Dermabond Prineo vs paper tape. Each continuous incision will be divided so that one half is covered with a standard dressing system and the other with SYLKE dressing. Randomization will occur preoperatively using a coin-flip application to determine which part of the incision receives SYLKE or standard dressing, with allocation concealed from the outcome assessor. The operating surgeon and the patient will not be blinded.
Dermabond Prineo
This randomized clinical trial will compare the performance of SYLKE, Dermabond Prineo, and paper tape in patients undergoing abdominoplasty or panniculectomy. For each patient, incision limbs - left vs. right for transverse incision and vertical vs. transverse for fleur-de-lis incision - will be randomized to receive either SYLKE or Dermabond Prineo vs paper tape. Each continuous incision will be divided so that one half is covered with a standard dressing system and the other with SYLKE dressing. Randomization will occur preoperatively using a coin-flip application to determine which part of the incision receives SYLKE or standard dressing, with allocation concealed from the outcome assessor. The operating surgeon and the patient will not be blinded.
Paper Tape
This randomized clinical trial will compare the performance of SYLKE, Dermabond Prineo, and paper tape in patients undergoing abdominoplasty or panniculectomy. For each patient, incision limbs - left vs. right for transverse incision and vertical vs. transverse for fleur-de-lis incision - will be randomized to receive either SYLKE or Dermabond Prineo vs paper tape. Each continuous incision will be divided so that one half is covered with a standard dressing system and the other with SYLKE dressing. Randomization will occur preoperatively using a coin-flip application to determine which part of the incision receives SYLKE or standard dressing, with allocation concealed from the outcome assessor. The operating surgeon and the patient will not be blinded.
Locations (1)
University of Missouri Hospital
Columbia, Missouri, United States