SYLKE Dressing for Scar Improvement
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Eamon O'Reilly, MD
Principal Investigator
MU Healthcare, Department of Surgery, Division of Plastic Surgery
Are You a Good Fit for This Trial?
This trial is for people who have had abdominoplasty (tummy tuck) or panniculectomy surgery. Participants should be able to use surgical dressings and not have conditions that would interfere with wound healing or cause allergic reactions to the dressings.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Dermabond Prineo
- Paper Tape
- SYLKE
Trial Overview
The study compares a new silk-based dressing called SYLKE with two common types of incisional dressings—Dermabond Prineo and paper tape—to see which works best for scar quality, skin reaction, and long-term healing after abdominal surgery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Missouri-Columbia
Lead Sponsor
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