Prospective Evaluation of Silk Fibroin Incision Dressings in ACL Reconstruction

Not Applicable

Not yet recruiting

• Conditions: Anterior Cruciate Ligament Reconstruction

• Registration Number: NCT07217613
• Lead Sponsor: NYU Langone Health

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 mesh closure in patients undergoing anterior cruciate ligament reconstruction.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study Start: 2025-10-14
• Study First Submitted: 2025-10-15
• Study First Submitted QC: 2025-10-15
• Last Update Submitted: 2025-10-15
• Study First Posted: 2025-10-16
• Last Update Posted: 2025-10-16
• Primary Completion: 2026-03
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 138

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 tobacco use within 30 days of surgery
• Active systemic infection at the time of enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence rate of postoperative skin complications (allergic contact dermatitis, blistering, erythema)	Follow-up 1 (7-14 days postoperatively)

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with intact dressing	Follow-up 2 (4-6 weeks postoperatively)
Participant reported comfort rating as assessed by the Visual Analogue Scale (VAS)	Follow-up 2 (4-6 weeks postoperatively)	Patients will complete a 0-10 VAS rating for comfort.
Participant reported itch rating as assessed by the VAS	Follow-up 2 (4-6 weeks postoperatively)	Patients will complete a 0-10 VAS rating for itch.
Rehabilitation Interference score	Follow-up 2 (4-6 weeks postoperatively)	A 5-point Likert scale (none → extreme) will assess the perceived impact of incision-related discomfort on physical therapy participation and return to activity.
Overall participant satisfaction rating as assessed by the VAS	Follow-up 2 (4-6 weeks postoperatively)	Patients will complete a 0-10 VAS rating for comfort.
Participant perceived scar quality score as assessed by the Patient and Observer Scar Assessment Scale (POSAS)	~1 year postoperative	POSAS v2.0 is validated for evaluating scar quality, including pigmentation, pliability, thickness, and overall cosmetic outcome. The scale consists of 6 items rated from 1 to 10. The total score ranges from 6 to 60. A score of 6 represents normal skin, while a score of 60 indicates the worst imaginable scar. The overall opinion question is rated separately and is not included in the total score.
Number of dressing-related complications requiring intervention	Day 30	Assessed via electronic medical record (EMR) review.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States