NCT07217613

Prospective Evaluation of Silk Fibroin Incision Dressings in ACL Reconstruction

Prospective Evaluation of Silk Fibroin Incision Dressings in ACL Reconstruction: A Biocompatible Alternative for High-Motion Surgical Sites

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 14 Years – 60 Years
• Healthy volunteers: Not accepted

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 mesh closure in patients undergoing anterior cruciate ligament reconstruction.

Conditions

• Anterior Cruciate Ligament Reconstruction

Interventions

Type	Name	Description
DEVICE	silk fibroin-based incision dressing	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).
DEVICE	cyanoacrylate-based closure system	Applied per standard NYU practice; dressing remains in place per routine protocol.

Timeline

• Start date: 2025-10-14
• Primary completion: 2026-03-01
• Completion: 2027-03-01
• First posted: 2025-10-16
• Last updated: 2025-10-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study