Rate of Allergic Contact Dermatitis and Cosmetic Outcomes

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06957444
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

West Virginia University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Benjamin Frye, MD
Principal Investigator Affiliation West Virginia University Department of Orthopaedics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Allergic Contact Dermatitis, Osteoarthritis, Hip, Osteoarthritis, Knee
Arms & Interventions

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

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

West Virginia University, Morgantown, West Virginia

Status

Address

West Virginia University

Morgantown, West Virginia, 26505

Site Contact

Benjamin Frye, MD

[email protected]

304-293-2485