An interventional study of SYLKE and Dermabond Prineo in Hypertrophic Surgical Scar and Medical Adhesive Related Skin Injury, sponsored by University of Missouri-Columbia. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Treatment
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.
317 studies on the registry are indexed under Cicatrix; 54 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 260 interventional studies indexed under Cicatrix.
Browse Cicatrix studies →University of Missouri-Columbia is the lead sponsor of 364 studies on the registry; 70 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 29 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
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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.
Device: SYLKE · Device: 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.
Device: SYLKE · Device: 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.
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.
Scar Quality
The primary outcome of this study is scar quality, which will be assessed at 1 month, 3 months, 6 months, and 12 months postoperatively. Standardized digital photographs will be taken at 1, 3, 6, and 12 months under controlled conditions, including a designated camera and a fixed distance for each photograph. Our institution has a standardized photography room, ensuring consistent lighting and a uniform blue background for all images. A blinded, board-certified plastic surgeon will evaluate de-identified photographs using the Patient and Observer Scar Assessment Scale (POSAS), a validated tool in which clinicians and patients independently assess scar appearance and overall scar formation. Patients will also independently assess their own scars at 1, 3, 6, and 12 months postoperatively using the Patient component of POSAS. POSAS is a validated tool for assessing scar appearance and overall scar formation, with separate clinician and patient components, and has been utilized with asses
Time frame: The expected study duration is 1.5 years as patients will be followed for 1 year.
Medical adhesive-related skin injuries (MARSIs)
Adverse events, including skin irritation, MARSIs, blistering, infection, and other wound complications, will be monitored, recorded at each follow-up visit, and managed according to standard clinical practice throughout the study period.
Time frame: The expected study duration is 1.5 years as patients will be followed for 1 year.
Plan to share: Yes
Start is estimated for Nov 2026; primary completion for Sep 2027, 10 months later.
Of 74 non-industry interventional studies with no phase under Cicatrix, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 10 months is below that.
Counting every sponsor, half of 88 studies reached it within 20 months; a quarter within 10 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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