Rate of Allergic Contact Dermatitis and Cosmetic Outcomes

West Virginia University

Status: Begins enrollment this month

Conditions: Osteoarthritis, Hip; Allergic Contact Dermatitis; Osteoarthritis, Knee

Treatments: Procedure: Suture Strip Plus; Procedure: Sylke Adhesive Dressing; Procedure: Exofin Skin Glue

Study type: Interventional

Funder types: Other

Identifiers

NCT06957444

2503134113

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing and able to sign the informed consent
• Patients presenting to the WVU Medicine Center for Joint Replacement who have a primary TKA or THA surgery scheduled
• Patients with surgical wounds closed by 2-0 vicryl and barbed, running v-loc suture (assessed in OR)
• Active MyChart account and the ability to take and upload a photo in that system

Exclusion criteria

• Patients scheduled for a revision THA or revision TKA
• THA used for treatment of a fracture
• Patients participating in other studies that might have involve medications such as antibiotics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

Sylke Adhesive Dressing

Active Comparator group

Description:

Topical Wound Closure to be applied once the deep wound closure is secured after Total Knee or Total Hip Arthroplasty

Treatment:

Procedure: Sylke Adhesive Dressing

Exofin Skin Glue

Active Comparator group

Description:

Topical Wound Closure to be applied once the deep wound closure is secured after Total Knee or Total Hip Arthroplasty

Treatment:

Procedure: Exofin Skin Glue

Suture Strip Plus

Active Comparator group

Description:

Topical Wound Closure to be applied once the deep wound closure is secured after Total Knee or Total Hip Arthroplasty

Treatment:

Procedure: Suture Strip Plus