Anterior Cruciate Ligament Reconstruction
Conditions
Keywords
ACL reconstruction, silk fibroin, cyanoacrylate, sports medicine, SYLKE, wound dressing, allergic contact dermatitis
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 and cyanoacrylate closure in patients undergoing anterior cruciate ligament reconstruction.
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.
Interventions
DEVICEsilk fibroin-based incision dressing
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).
DEVICEcyanoacrylate-based closure system
Applied per standard NYU practice; dressing remains in place per routine protocol.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of postoperative skin complications | Follow-up 1 (7-14 days postoperatively) | Incidence of allergic contact dermatitis, blistering, erythema, or other incision-related complications, assessed by the clinical team. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dressing-related complications requiring intervention. | approximately 30 days postoperatively | An independent, blinded review of 30-day wound-related events performed by a separate team member via EMR review. |
| Rehabilitation Interference score | approximately 30 days postoperatively | A 5-point Likert scale (none to extreme) will assess the perceived impact of incision-related discomfort on physical therapy participation and return to activity. |
| Participant-reported incision-site pain rating (VAS) | approximately 30 days postoperatively | Patients will complete a 0-10 VAS rating for incision site pain. |
| Overall participant satisfaction rating (VAS) | approximately 30 days postoperatively | Patients will complete a 0-10 VAS rating for satisfaction with the incision dressing. |
| Participant reported comfort rating (VAS) | Approximately 30 days postoperatively | Participants will complete a 0-10 VAS rating for incision site comfort. |
| Participant and observer scar quality (POSAS v2.0) | 3 Months Post-Operatively | POSAS v2.0 evaluates scar quality across pigmentation, pliability, thickness, and overall cosmetic outcome (6 items, 1-10 each; total 6-60, where 6 = normal skin and 60 = worst imaginable scar). The patient component is self-reported by the participant. The observer component is scored by one unblinded clinical assessor and two fully blinded independent raters; observer item-level scores are averaged across raters, with a pre-specified sensitivity analysis using only the two blinded raters. |
| Participant-reported itch rating (VAS) | approximately 30 days postoperatively | Participants will complete a 0-10 VAS rating for itch. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREric J. Strauss, MD
NYU Langone Health
Outcome results
None listed