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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests three different wound closure products to determine which works best for individuals undergoing knee or hip replacement surgery. Participants will use one of the following products: Sylke adhesive dressing, Exofin skin glue, or Suture Strip Plus. Doctors will assess how well their incisions heal. The trial seeks individuals planning a primary total knee or hip replacement who can use MyChart to upload photos of their wounds. As an unphased trial, this study allows participants to contribute to research that could enhance post-surgical care for future patients.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Exofin Skin Glue, used for wound closure, has been linked to some skin reactions due to its adhesive ingredient. A review found 193 cases of allergic reactions to similar adhesives. However, these skin glues are generally valued for their strength and quick drying.

Suture Strip Plus, another wound closure product, is usually well-tolerated. Many patients prefer medical adhesives like Suture Strip Plus because they often require less follow-up care. Reports of allergic reactions to these adhesives exist but are uncommon.

The Sylke Adhesive Dressing is known for a low rate of wound problems. It uses silk fibroin, which rarely causes allergic reactions, even in joint replacements.

Overall, while allergic reactions can occur with these products, they are generally rare. Most patients tolerate these wound closure methods well. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these wound closure products for allergic contact dermatitis because they offer new ways to secure surgical wounds after major procedures like knee or hip replacement. Unlike traditional sutures or staples, Exofin Skin Glue provides a seamless adhesive solution that can reduce scarring and improve healing time. Suture Strip Plus is a unique adhesive strip that combines the benefits of a suture with the simplicity of a bandage, potentially enhancing comfort and minimizing irritation. Sylke Adhesive Dressing offers a breathable yet secure closure, which helps in reducing the risk of infection while promoting a cleaner healing environment. Each option provides a different approach to wound closure, offering more flexibility and potentially better outcomes for patients with sensitive skin.

What evidence suggests that this trial's wound closure products could be effective for allergic contact dermatitis?

Research has shown that Exofin Skin Glue, one of the treatments in this trial, effectively closes wounds, with results comparable to other methods in reducing wound complications. It lowers the risk of both surface and deeper wound issues, aiding in better healing. Suture Strip Plus, another treatment option in this trial, performs as well as traditional stitches, making it a reliable choice for wound closure. Studies indicate that Sylke Adhesive Dressing, also tested in this trial, uses silk protein to significantly reduce healing problems and support good healing. Overall, these treatments have proven effective in aiding wound closure and reducing complications in patients. ^{1 3 4 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. clinicaltrials.gov clinicaltrials.gov/study/NCT06957444

Rate of Allergic Contact Dermatitis and Cosmetic Outcomes 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7242402/

Wound Complications after 2-Octyl Skin Closure Systems ... The results of this study show that the Dermabond/Prineo and Exofin Fusion systems both show a similar amount of superficial and deep wound complications and ...

3. liebertpub.com liebertpub.com/doi/10.1089/derm.2023.0342

Allergic Contact Dermatitis to Octyl Cyanoacrylate Skin ... This systematic review includes 193 reported cases of ACD due to cyanoacrylate adhesive application for wound closure, detailing symptoms, risk factors and ...

4. withpower.com withpower.com/trial/wound-closure-products-for-allergic-contact-dermatitis-14647

Wound Closure Products for Allergic Contact Dermatitis What data supports the effectiveness of the treatment Exofin Skin Glue, Suture Strip Plus, Sylke Adhesive Dressing for allergic contact dermatitis? The research ...

5. researchgate.net researchgate.net/figure/Primary-Outcomes-Superficial-and-Deep-Wound-Complications_tbl1_340693390

Superficial and Deep Wound Complications Meta-analysis identified a statistically significant reduction in wound infection rates (Dermabond Prineo 1.51%, control 2.13%; OR: 0.65 (0.46, 0.91); p=0.01) ...

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9322325&pc=OMD

MAUDE Adverse Event Report: EXOFIN SKIN GLUE Used for skin closure in the operating room.We have been seeing a number of these lately and gave stopped using the product.Fda safety report id# (b)(4).

7. researchgate.net researchgate.net/publication/378399533_Allergic_Contact_Dermatitis_to_Octyl_Cyanoacrylate_Skin_Glue_After_Surgical_Wound_Closure_A_Systematic_Review

Allergic Contact Dermatitis to Octyl Cyanoacrylate Skin ... Designed to close wounds, connect tissues, or replace sutures, they offer numerous advantages including durability and (generally) rapid polymerisation [4] ...