Prospective Evaluation of Silk Fibroin Incision Dressings in ACL Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-60
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- silk fibroin-based incision dressing
- cyanoacrylate-based closure system
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov