Rate of Allergic Contact Dermatitis and Cosmetic Outcomes

Part of paid clinical trials in Morgantown, West Virginia.

Sponsor
West Virginia University
Study ID
NCT06957444
Status
Enrolling By Invitation

Conditions

  • Allergic Contact Dermatitis
  • Osteoarthritis, Hip
  • Osteoarthritis, Knee

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Sylke Adhesive Dressing — PROCEDURE
    Topical wound closure device, made from silk fibroin woven mesh coated with a pressure-sensitive acrylic adhesive.
  • Exofin Skin Glue — PROCEDURE
    2-octil cyanoacrylate formulation, applied using a soft and flexible applicator.
  • Suture Strip Plus — PROCEDURE
    Flexible wound closure strip designed for primary wound closure made up of macroporous non-woven polyamide with a pressure sensitive adhesive.

Study Details

The patients from the Department of Orthopaedics Center for Joint Replacement will be asked to participate in the study. These patients will be randomized to one of three wound closure products, Sylke adhesive dressing, Exofin skin glue, or Suture Strip Plus. Participants will be asked to take a photograph of the incision 4 days after surgery to submit via MyChart for review by the WVU Department of Dermatology Team. All patients will be evaluated at their regular 2-week, 6-week, and 3-month post-operative visits where clinical photographs will be submitted for independent review by the WVU Department of Dermatology Team to assess outcomes.

Key Dates

Start date
Oct 13, 2025
Status verified
May 2026
Primary completion
May 31, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Sylke Adhesive Dressing
    Topical Wound Closure to be applied once the deep wound closure is secured after Total Knee or Total Hip Arthroplasty
  • Active Comparator: Exofin Skin Glue
    Topical Wound Closure to be applied once the deep wound closure is secured after Total Knee or Total Hip Arthroplasty
  • Active Comparator: Suture Strip Plus
    Topical Wound Closure to be applied once the deep wound closure is secured after Total Knee or Total Hip Arthroplasty

Primary Outcome Measure

Rate of allergic contact dermatitis (4 Days Post Op) [ Time Frame: 4 Days Post-Op ]

Locations (1)

FacilityCityStateZIPSite coordinators
West Virginia UniversityMorgantownWest Virginia26505-

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West Virginia University· Morgantown, WV

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