Wound Closure Products for Allergic Contact Dermatitis

Overseen By Jenn Eicher, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: West Virginia University

Must not be taking: Antibiotics

Disqualifiers: Revision THA, Revision TKA, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 3 months

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this 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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are participating in other studies that involve medications like antibiotics, you may be excluded from this trial.

Is it safe to use wound closure products like Exofin Skin Glue for allergic contact dermatitis?

Wound closure products like skin adhesives can cause allergic contact dermatitis (skin irritation) in some people, with a small percentage (2.8%) experiencing mild symptoms like eczema and itching, which usually resolve without complications. ^{1 2 3 4 5}

How does the treatment for allergic contact dermatitis using Exofin Skin Glue, Suture Strip Plus, and Sylke Adhesive Dressing differ from other treatments?

This treatment is unique because it uses skin adhesives and dressings specifically designed for wound closure, which may reduce the risk of infection and improve healing compared to traditional methods. However, there is a small risk of allergic contact dermatitis, which is a skin reaction that can occur with these materials. ^{1 2 3 5 6}

What data supports the effectiveness of the treatment Exofin Skin Glue, Suture Strip Plus, Sylke Adhesive Dressing for allergic contact dermatitis?

The research indicates that skin adhesives, like those used in the treatment, can cause contact dermatitis in some patients, with one study showing a 14% incidence of dermatitis after using cyanoacrylate-based adhesives. However, these adhesives are commonly used for wound closure, suggesting they are effective for this purpose, but patients should be aware of the potential for allergic reactions. ^{1 3 5 6 7}

Who Is on the Research Team?

Benjamin Frye, MD

Principal Investigator

West Virginia University Department of Orthopaedics

Are You a Good Fit for This Trial?

This trial is for patients at the WVU Medicine Center for Joint Replacement scheduled for primary total knee (TKA) or hip arthroplasty (THA). They must be able to consent, have their surgical wounds closed with specific sutures, and use MyChart to upload photos. Those with revision surgeries, THA due to fractures, or in other drug-related studies can't join.

Inclusion Criteria

Willing and able to sign the informed consent

I am scheduled for a primary knee or hip replacement at WVU Medicine Center.

My surgical wound was closed with specific stitches.

Exclusion Criteria

I had a hip replacement due to a fracture.

I am not in any studies that involve taking medications.

I am scheduled for a hip or knee replacement revision surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to one of three wound closure products and monitored for allergic contact dermatitis and cosmetic outcomes

3 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exofin Skin Glue
• Suture Strip Plus
• Sylke Adhesive Dressing

Trial Overview The study compares three wound closure methods after joint replacement surgery: Sylke adhesive dressing, Exofin skin glue, and Suture Strip Plus. Patients are randomly assigned a method and submit incision photos post-surgery for evaluation at regular follow-up visits by dermatology experts.

How Is the Trial Designed?

Group I: Sylke Adhesive Dressing Active Control 1 Intervention

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

Group II: Exofin Skin Glue Active Control 1 Intervention

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

Group III: Suture Strip Plus Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+

Published Research Related to This Trial

This study reports the first confirmed case of allergic contact dermatitis (ACD) in a child specifically caused by wound closure tape, known as Steri-Strips™.

The findings highlight the potential for wound care products, including medical adhesives and closure tapes, to cause allergic reactions, emphasizing the need for awareness and monitoring in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allergic contact dermatitis caused by wound closure tape in a pediatric patient. Tam, I., Yu, J.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Postoperative contact dermatitis caused by skin adhesives used in orthopedic surgery: Incidence, characteristics, and difference from surgical site infection. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled comparison of cosmetic outcomes of simple facial lacerations closed with Steri Strip Skin Closures or Dermabond tissue adhesive. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Characterizing the Diagnosis and Treatment of Allergic Contact Dermatitis to 2-Octyl Cyanoacrylate Used for Skin Closure in Elective Orthopedic Surgery. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Contact Dermatitis in the Surgical Patient: A Focus on Wound Closure Materials. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Should We Stick with Surgical Glues? The Incidence of Dermatitis after 2-Octyl Cyanoacrylate Exposure in 102 Consecutive Breast Cases. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Allergic contact dermatitis caused by wound closure tape in a pediatric patient. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Adhesive strips as the sole method for skin closure is effective in total knee arthroplasty. [2020]