Prospective Evaluation of Silk Fibroin Incision Dressings in ACL Reconstruction

N/ANot Yet RecruitingNCT07217613

NYU Langone Health138 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

138

Conditions

Anterior Cruciate Ligament Reconstruction

Interventions

silk fibroin-based incision dressingDEVICE

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 systemDEVICE

Applied per standard NYU practice; dressing remains in place per routine protocol.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 60 Years

Medical Language ↔ Plain English

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 tobacco use within 30 days of surgery * Active systemic infection at the time of enrollment

Locations (1)

NYU Langone Health

New York, New York, United States

Outcomes

Primary Outcomes

Incidence rate of postoperative skin complications (allergic contact dermatitis, blistering, erythema)

Time frame: Follow-up 1 (7-14 days postoperatively)