Prospective Evaluation of Silk Fibroin Versus 2-Octyl Cyanoacrylate Incision Dressings Following ACL Reconstruction
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to compare the incidence of early postoperative skin complications including allergic contact dermatitis, blistering, and erythema between silk fibroin incision dressings and cyanoacrylate closure in patients undergoing anterior cruciate ligament reconstruction.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 60
Healthy Volunteers: f
View:
• 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
Locations
United States
New York
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Layne Estes
layne.estes@nyulangone.org
(646) 501-7208
Backup
Eric J. Straus, MD
eric.strauss@nyulangone.org
(646) 501-7208
Time Frame
Start Date: 2025-10-14
Estimated Completion Date: 2026-07
Participants
Target number of participants: 100
Treatments
Experimental: Silk fibroin adhesive incision dressing
Participants will receive the silk fibroin adhesive incision dressing following anterior cruciate ligament reconstruction (ACLR).
Active_comparator: Standard closure dressing
Participants will receive the standard-of-care incision management currently used in ACL reconstruction at NYU Langone Orthopedic Surgery, consisting of cyanoacrylate-based closure systems (e.g., Dermabond® or Prineo®) as determined by the operating surgeon.
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health