Prospective Evaluation of Silk Fibroin Incision Dressings in ACL Reconstruction

NYU Langone Health

Status: Not yet enrolling

Conditions: Anterior Cruciate Ligament Reconstruction

Treatments: Device: cyanoacrylate-based closure system; Device: silk fibroin-based incision dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT07217613

25-01002

Details and patient eligibility

About

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.

Enrollment: 138 estimated patients

Sex: All

Ages: 14 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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138 participants in 3 patient groups

Silk fibroin adhesive incision dressing

Experimental group

Description:

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

Treatment:

Device: silk fibroin-based incision dressing

Standard closure dressing

Active Comparator group

Description:

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.

Treatment:

Device: cyanoacrylate-based closure system

Bilateral procedures

Experimental group

Description:

For bilateral procedures (contralateral patellar tendon harvest for autograft), a within-subject design will be employed: one incision site will receive silk fibroin and the other cyanoacrylate, with side assignment randomized.

Treatment:

Device: silk fibroin-based incision dressing

Device: cyanoacrylate-based closure system