Prospective Evaluation of Silk Fibroin Incision Dressings in ACL Reconstruction

NYU Langone Health100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

100

Conditions

Anterior Cruciate Ligament Reconstruction

Interventions

silk fibroin-based incision dressingDEVICE

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).

cyanoacrylate-based closure systemDEVICE

Applied per standard NYU practice; dressing remains in place per routine protocol.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

NYU Langone Health

New York, New York, United States

Outcomes

Primary Outcomes

Incidence rate of postoperative skin complications

Incidence of allergic contact dermatitis, blistering, erythema, or other incision-related complications, assessed by the clinical team.

Time frame: Follow-up 1 (7-14 days postoperatively)

Secondary Outcomes

Participant reported comfort rating (VAS)

Participants will complete a 0-10 VAS rating for incision site comfort.

Time frame: Approximately 30 days postoperatively

Participant-reported itch rating (VAS)

Participants will complete a 0-10 VAS rating for itch.

Time frame: approximately 30 days postoperatively

Rehabilitation Interference score

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.

Time frame: approximately 30 days postoperatively

Participant-reported incision-site pain rating (VAS)

Patients will complete a 0-10 VAS rating for incision site pain.

Time frame: approximately 30 days postoperatively

Overall participant satisfaction rating (VAS)

Patients will complete a 0-10 VAS rating for satisfaction with the incision dressing.

Time frame: approximately 30 days postoperatively

Participant and observer scar quality (POSAS v2.0)

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.

Data from ClinicalTrials.gov

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