Prospective Evaluation of Silk Fibroin Incision Dressings in ACL Reconstruction

NCT07217613 | Recruiting FDA Device

• 1 other identifier: 25-01002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

ACL reconstruction; silk fibroin; cyanoacrylate; sports medicine; SYLKE; wound dressing; allergic contact dermatitis

Outcome Measures

Primary Outcomes (1)

• Incidence rate of postoperative skin complications

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

  Follow-up 1 (7-14 days postoperatively)

Secondary Outcomes (7)

• Participant reported comfort rating (VAS)

  Approximately 30 days postoperatively

• Participant-reported itch rating (VAS)

  approximately 30 days postoperatively

• Rehabilitation Interference score

  approximately 30 days postoperatively

• Participant-reported incision-site pain rating (VAS)

  approximately 30 days postoperatively

• Overall participant satisfaction rating (VAS)

  approximately 30 days postoperatively

Study Arms (2)

Silk fibroin adhesive incision dressing

EXPERIMENTAL

Participants will receive the silk fibroin adhesive incision dressing following anterior cruciate ligament reconstruction (ACLR).

Device: silk fibroin-based incision dressing

Standard closure dressing

ACTIVE COMPARATOR

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.

Device: cyanoacrylate-based closure system

Interventions

cyanoacrylate-based closure system DEVICE

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

Also known as: Dermabond®, Prineo®

Standard closure dressing

silk fibroin-based incision dressing DEVICE

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).

Also known as: SYLKE®, SYLKE Inc.

Silk fibroin adhesive incision dressing

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Dermatitis, Allergic Contact

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Eric J. Strauss, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Layne Estes

CONTACT

(646) 501-7208; layne.estes@nyulangone.org

Eric J. Straus, MD

CONTACT

(646) 501-7208; eric.strauss@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: October 16, 2025
• Study Start: October 14, 2025
• Primary Completion: May 1, 2026
• Study Completion: July 1, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)