Status:
NOT_YET_RECRUITING
Prospective Evaluation of Silk Fibroin Incision Dressings in ACL Reconstruction
Lead Sponsor:
NYU Langone Health
Conditions:
Anterior Cruciate Ligament Reconstruction
Eligibility:
All Genders
14-60 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT07217613
Start Date
October 14 2025
End Date
March 1 2027
Last Update
October 16 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016