University of Missouri-Columbia
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 wou…
Inclusion Criteria: Patients 18 years of age or older Patients scheduled to undergo abdominoplasty or panniculectomy The patient is able to provide informed consent and is willing to comply with the follow-up schedule Exclusion Criteria: Patients under 18 years of age Patients with a known allergy or sensitivity to silk-based products Patients with known allergy to 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.
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.
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