Prospective Evaluation of Silk Fibroin Incision Dressings in ACL Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-60
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
silk fibroin-based incision dressing
DeviceApplied 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
DeviceApplied per standard NYU practice; dressing remains in place per routine protocol.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Silk fibroin adhesive incision dressingExperimental treatment 1 intervention
Group B: Standard closure dressingActive comparator 1 intervention
Trial outcomes
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.
Time frame
Follow-up 1 (7-14 days postoperatively)Secondary outcomes
1
Participant reported comfort rating (VAS)
Participants will complete a 0-10 VAS rating for incision site comfort.
Time frame
Approximately 30 days postoperatively2
Participant-reported itch rating (VAS)
Participants will complete a 0-10 VAS rating for itch.
Time frame
approximately 30 days postoperatively3
Rehabilitation Interference score
A 5-point Likert scale (none to extreme) will assess the perceived impact of incision-related discomfort on physical therapy participation and return to activity.
Time frame
approximately 30 days postoperatively4
Participant-reported incision-site pain rating (VAS)
Patients will complete a 0-10 VAS rating for incision site pain.
Time frame
approximately 30 days postoperativelySponsors and contacts
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Source ClinicalTrials.gov