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Prospective Evaluation of Silk Fibroin Incision Dressings in ACL Reconstruction

NCT07217613 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Anterior Cruciate Ligament Reconstruction

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Eric J. Strauss, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-14
Primary Completion
2026-05-31
Completion
2026-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07217613 on ClinicalTrials.gov