Rate of Allergic Contact Dermatitis and Cosmetic Outcomes

May 6, 2026 updated by: Benjamin Frye, West Virginia University

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- West Virginia
  - Morgantown, West Virginia, United States, 26505
    - West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Procedure: Sylke Adhesive Dressing Topical wound closure device, made from silk fibroin woven mesh coated with a pressure-sensitive acrylic adhesive.
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	Procedure: Exofin Skin Glue 2-octil cyanoacrylate formulation, applied using a soft and flexible applicator.
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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of allergic contact dermatitis (4 Days Post Op) Time Frame: 4 Days Post-Op	Percentage of participants exhibiting allergic contact dermatitis as determined by using the International Contact Dermatitis Research Group (ICDRG) scale with any reaction including and above "Weak Positive" being included in this rate of allergic contact dermatitis: Negative (0): No reaction. Doubtful (+?): Slight erythema (redness) without infiltration. Weak positive (+): Erythema, infiltration, possibly papules. Strong positive (++): Erythema, infiltration, papules, vesicles. Extreme positive (+++): Intense erythema, infiltration, coalescing vesicles, bullous reaction.	4 Days Post-Op
Rate of allergic contact dermatitis (2 Weeks Post Op) Time Frame: 2 Weeks Post-Op	Percentage of participants exhibiting allergic contact dermatitis as determined by using the International Contact Dermatitis Research Group (ICDRG) scale with any reaction including and above "Weak Positive" being included in this rate of allergic contact dermatitis: Negative (0): No reaction. Doubtful (+?): Slight erythema (redness) without infiltration. Weak positive (+): Erythema, infiltration, possibly papules. Strong positive (++): Erythema, infiltration, papules, vesicles. Extreme positive (+++): Intense erythema, infiltration, coalescing vesicles, bullous reaction.	2 Weeks Post-Op
Rate of allergic contact dermatitis (6 Weeks Post Op) Time Frame: 6 Weeks Post-Op	Percentage of participants exhibiting allergic contact dermatitis as determined by using the International Contact Dermatitis Research Group (ICDRG) scale with any reaction including and above "Weak Positive" being included in this rate of allergic contact dermatitis: Negative (0): No reaction. Doubtful (+?): Slight erythema (redness) without infiltration. Weak positive (+): Erythema, infiltration, possibly papules. Strong positive (++): Erythema, infiltration, papules, vesicles. Extreme positive (+++): Intense erythema, infiltration, coalescing vesicles, bullous reaction.	6 Weeks Post-Op
Rate of allergic contact dermatitis (3 Months Post Op) Time Frame: 3 Months Post-Op	Percentage of participants exhibiting allergic contact dermatitis as determined by using the International Contact Dermatitis Research Group (ICDRG) scale with any reaction including and above "Weak Positive" being included in this rate of allergic contact dermatitis: Negative (0): No reaction. Doubtful (+?): Slight erythema (redness) without infiltration. Weak positive (+): Erythema, infiltration, possibly papules. Strong positive (++): Erythema, infiltration, papules, vesicles. Extreme positive (+++): Intense erythema, infiltration, coalescing vesicles, bullous reaction.	3 Months Post-Op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Cosmetic Outcome (4 Days Post-Op) Time Frame: 4 Days Post-Op	The Scar Cosmesis Assessment and Rating (SCAR) scale is a validated tool used to assess the quality of postoperative scars. The SCAR scale measures postoperative scar cosmesis with scores ranging from 0 (best possible scar) to 15 (worst possible scar). The assessment includes both clinician and patient items, ensuring a comprehensive evaluation.	4 Days Post-Op
Difference in Cosmetic Outcome (2 Weeks Post-Op) Time Frame: 2 Weeks Post-Op	The Scar Cosmesis Assessment and Rating (SCAR) scale is a validated tool used to assess the quality of postoperative scars. The SCAR scale measures postoperative scar cosmesis with scores ranging from 0 (best possible scar) to 15 (worst possible scar). The assessment includes both clinician and patient items, ensuring a comprehensive evaluation.	2 Weeks Post-Op
Difference in Cosmetic Outcome (6 Weeks Post-Op) Time Frame: 6 Weeks Post-Op	The Scar Cosmesis Assessment and Rating (SCAR) scale is a validated tool used to assess the quality of postoperative scars. The SCAR scale measures postoperative scar cosmesis with scores ranging from 0 (best possible scar) to 15 (worst possible scar). The assessment includes both clinician and patient items, ensuring a comprehensive evaluation.	6 Weeks Post-Op
Difference in Cosmetic Outcome (3 Months Post-Op) Time Frame: 3 Months Post-Op	The Scar Cosmesis Assessment and Rating (SCAR) scale is a validated tool used to assess the quality of postoperative scars. The SCAR scale measures postoperative scar cosmesis with scores ranging from 0 (best possible scar) to 15 (worst possible scar). The assessment includes both clinician and patient items, ensuring a comprehensive evaluation.	3 Months Post-Op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Virginia University

Investigators

Principal Investigator: Benjamin Frye, MD, West Virginia University Department of Orthopaedics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

April 25, 2025

First Submitted That Met QC Criteria

April 25, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

2503134113

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Rate of Allergic Contact Dermatitis and Cosmetic Outcomes