Prospective Evaluation of Silk Fibroin Incision Dressings in ACL Reconstruction
NCT ID: NCT07217613
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
138 participants
INTERVENTIONAL
2025-10-14
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Silk fibroin adhesive incision dressing
Participants will receive the silk fibroin adhesive incision dressing following anterior cruciate ligament reconstruction (ACLR).
silk 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).
Standard closure dressing
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.
cyanoacrylate-based closure system
Applied per standard NYU practice; dressing remains in place per routine protocol.
Bilateral procedures
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.
silk 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).
cyanoacrylate-based closure system
Applied per standard NYU practice; dressing remains in place per routine protocol.
Interventions
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silk 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).
cyanoacrylate-based closure system
Applied per standard NYU practice; dressing remains in place per routine protocol.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
14 Years
60 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Eric J. Strauss, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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25-01002
Identifier Type: -
Identifier Source: org_study_id
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