Prospective Evaluation of Silk Fibroin Incision Dressings in ACL Reconstruction

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07217613
Status
Recruiting
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Conditions

  • Anterior Cruciate Ligament Reconstruction

Eligibility Criteria

Sex
ALL
Age
14 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • silk fibroin-based incision dressing — DEVICE
    Applied sterile, hydrophobic, hypoallergenic dressing remains in place for 14-21 days, unless removal is clinically indicated (e.g., saturation, detachment, suspected allergic contact dermatitis, or at provider discretion).
  • cyanoacrylate-based closure system — DEVICE
    Applied per standard NYU practice; dressing remains in place per routine protocol.

Study Details

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.

Key Dates

Start date
Oct 14, 2025
Status verified
May 2026
Primary completion
May 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

Incidence rate of postoperative skin complications [ Time Frame: Follow-up 1 (7-14 days postoperatively) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By research site
NYU Langone Health· New York, NY

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