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 independent of allocation.

The primary outcome is the incidence of early postoperative skin complications, including allergic contact dermatitis, blistering, erythema, and other incision-related complications, assessed at the first postoperative visit (7-14 days). Secondary outcomes include patient-reported comfort, itch, incision-site pain, satisfaction, and rehabilitation interference at approximately 30 days; dressing-related complications requiring clinical intervention through 30 days, captured via blinded electronic medical record review; and scar quality at a minimum of 3 months postoperatively using the Patient and Observer Scar Assessment Scale (POSAS v2.0), with the observer component scored by one unblinded clinical assessor and two fully blinded independent raters.

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 systemic infection at the time of enrollment

This is a single-site, minimal-risk device study. Only aggregate results will be disseminated; individual datasets will not be shared. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: layne.estes@nyulangone.org or riley.mcconnell@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.