Rate of Allergic Contact Dermatitis and Cosmetic Outcomes

Not Applicable

Not yet recruiting

• Conditions: Allergic Contact Dermatitis; Osteoarthritis, Hip; Osteoarthritis, Knee

• Registration Number: NCT06957444
• Lead Sponsor: West Virginia University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-25
• Study First Submitted QC: 2025-04-25
• Last Update Submitted: 2025-04-25
• Study First Posted: 2025-05-04
• Last Update Posted: 2025-05-04
• Study Start: 2025-06
• Primary Completion: 2028-01
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of allergic contact dermatitis (4 Days Post Op)	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.
Rate of allergic contact dermatitis (2 Weeks Post Op)	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.
Rate of allergic contact dermatitis (6 Weeks Post Op)	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.
Rate of allergic contact dermatitis (3 Months Post Op)	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 Outcome Measures

Name	Time	Method
Difference in Cosmetic Outcome (4 Days Post-Op)	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.
Difference in Cosmetic Outcome (2 Weeks Post-Op)	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.
Difference in Cosmetic Outcome (6 Weeks Post-Op)	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.
Difference in Cosmetic Outcome (3 Months Post-Op)	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.

Trial Locations

Locations (1)

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States