NYU Langone Health
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.
This is a prospective, randomized, parallel-group controlled trial conducted at a single academic medical center comparing a silk fibroin adhesive incision dressing (SYLKE) to a cyanoacrylate-based skin closure system (Dermabond or Prineo) in patients undergoing primary or revision anterior cruciate ligament reconstruction (ACLR). Participants are randomized 1:1 using a computer-generated allocation sequence stratified by operating surgeon. Wound closure is standardized across all participants prior to dressing application, ensuring that deep and dermal closure are identical between groups and…
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…
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).
Applied per standard NYU practice; dressing remains in place per routine protocol.
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