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Enrolling by Invitation

NCT Number: NCT06957444

Rate of Allergic Contact Dermatitis and Cosmetic Outcomes

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.

Enrolling by Invitation

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Key information

Conditions

Allergic Contact Dermatitis Arthritis Dermatitis Dermatitis, Allergic Contact Dermatitis, Contact Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Rheumatic Diseases Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Virginia University

Morgantown, West Virginia, 26505, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sylke Adhesive Dressing

Procedure

Topical wound closure device, made from silk fibroin woven mesh coated with a pressure-sensitive acrylic adhesive.

Exofin Skin Glue

Procedure

2-octil cyanoacrylate formulation, applied using a soft and flexible applicator.

Suture Strip Plus

Procedure

Flexible wound closure strip designed for primary wound closure made up of macroporous non-woven polyamide with a pressure sensitive adhesive.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 4, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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