Silk fibroin versus cyanoacrylate incision dressings after ACL reconstruction
Prospective Evaluation of Silk Fibroin Versus 2-Octyl Cyanoacrylate Incision Dressings Following ACL Reconstruction
This will see if a silk fibroin adhesive dressing (SYLKE) or a cyanoacrylate skin closure causes fewer early skin problems in people having ACL reconstruction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 14 Years to 60 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07217613 on ClinicalTrials.gov |
What this trial studies
This is a single-center, prospective, randomized, parallel-group trial at NYU Langone comparing a silk fibroin adhesive incision dressing (SYLKE) to a cyanoacrylate-based closure (Dermabond or Prineo) in patients undergoing primary or revision ACL reconstruction. Participants are randomized 1:1 with allocation stratified by operating surgeon and receive standardized deep and dermal closure before the assigned dressing is applied. The primary outcome is the incidence of early postoperative skin complications (allergic contact dermatitis, blistering, erythema, and other incision-related issues) assessed at the first postoperative visit (7–14 days). Secondary outcomes include patient-reported comfort, itch, pain, satisfaction, rehabilitation interference at ~30 days, dressing-related complications through 30 days, and scar quality at ≥3 months using the POSAS v2.0 with both blinded and unblinded observer ratings.
Who should consider this trial
Good fit: People aged 14–60 who are scheduled for primary or revision ACL reconstruction and who can provide informed consent (or assent with parental permission for ages 14–17) and attend study follow-up visits are ideal candidates.
Not a fit: Patients with active skin disease at the surgical site, immunocompromised states, known or suspected allergy to silk or cyanoacrylate, uncontrolled diabetes, or active systemic infection are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the silk fibroin dressing could reduce early postoperative skin reactions and improve comfort and scar outcomes after ACL surgery.
How similar studies have performed: Cyanoacrylate closure systems like Dermabond/Prineo are widely used and generally effective, while silk fibroin incision dressings are a newer approach with limited prior clinical data in ACL surgery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 14 to 60 years * Scheduled for primary or revision ACL reconstruction (ACLR) * Able and willing to provide informed consent (≥18 years) or assent with parental/guardian permission (ages 14-17) * Able and willing to comply with all study-related procedures and follow-up visits Exclusion Criteria: * Active dermatologic conditions at or near the surgical site (e.g., eczema, psoriasis, dermatitis, open wounds) * Immunocompromised state (e.g., uncontrolled HIV, ongoing chemotherapy, chronic corticosteroid therapy) * Known or suspected allergy or hypersensitivity to silk fibroin or cyanoacrylate adhesives * Uncontrolled diabetes (defined as most recent HbA1c ≥ 8.0, if available; not measured for study purposes) * Active systemic infection at the time of enrollment
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Eric J. Strauss, MD — NYU Langone Health
- Study coordinator: Layne Estes
- Email: layne.estes@nyulangone.org
- Phone: (646) 501-7208
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.