NCT06957444

Rate of Allergic Contact Dermatitis and Cosmetic Outcomes

Rate of Allergic Contact Dermatitis and Cosmetic Outcomes for Three Wound Closure Techniques in Joint Arthroplasty Patients: A Randomized, Controlled Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: West Virginia University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2025-07-21
• Primary completion: 2028-02-01
• Completion: 2028-06-01
• First posted: 2025-05-04
• Last updated: 2025-07-28

Locations

1 site across 1 country: United States