Prospective Evaluation of Silk Fibroin Incision Dressings in ACL Reconstruction
Purpose
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.
Condition
- Anterior Cruciate Ligament Reconstruction
Eligibility
- Eligible Ages
- Between 14 Years and 60 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Silk fibroin adhesive incision dressing |
Participants will receive the silk fibroin adhesive incision dressing following anterior cruciate ligament reconstruction (ACLR). |
|
|
Active Comparator Standard closure dressing |
Participants will receive the standard-of-care incision management currently used in ACL reconstruction at NYU Langone Orthopedic Surgery, consisting of cyanoacrylate-based closure systems (e.g., Dermabond® or Prineo®) as determined by the operating surgeon. |
|
Recruiting Locations
New York, New York 10016
More Details
- Status
- Recruiting
- Sponsor
- NYU Langone Health
Detailed Description
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.