Prospective Evaluation of Silk Fibroin Incision Dressings in ACL Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: silk fibroin-based incision dressing, cyanoacrylate-based closure system.
- Who it may be relevant to
- Registry conditions: Anterior Cruciate Ligament Reconstruction. Basic parameters: 14 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Evaluation of Silk Fibroin Versus 2-Octyl Cyanoacrylate Incision Dressings Following ACL Reconstruction
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.
Detailed description
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.
Interventions
- Device 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). - Device cyanoacrylate-based closure system
Applied per standard NYU practice; dressing remains in place per routine protocol.
Primary outcome measures
- Incidence rate of postoperative skin complications [Time frame: Follow-up 1 (7-14 days postoperatively)]
Secondary outcome measures (7)
- Participant reported comfort rating (VAS) [Time frame: Approximately 30 days postoperatively]
- Participant-reported itch rating (VAS) [Time frame: approximately 30 days postoperatively]
- Rehabilitation Interference score [Time frame: approximately 30 days postoperatively]
- Participant-reported incision-site pain rating (VAS) [Time frame: approximately 30 days postoperatively]
- Overall participant satisfaction rating (VAS) [Time frame: approximately 30 days postoperatively]
- Participant and observer scar quality (POSAS v2.0) [Time frame: 3 Months Post-Operatively]
- Dressing-related complications requiring intervention. [Time frame: approximately 30 days postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT07217613 · 25-01002