Allergic Contact Dermatitis, Osteoarthritis, Hip, Osteoarthritis, Knee
Conditions
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.
Interventions
PROCEDURESylke Adhesive Dressing
Topical wound closure device, made from silk fibroin woven mesh coated with a pressure-sensitive acrylic adhesive.
PROCEDUREExofin Skin Glue
2-octil cyanoacrylate formulation, applied using a soft and flexible applicator.
PROCEDURESuture Strip Plus
Flexible wound closure strip designed for primary wound closure made up of macroporous non-woven polyamide with a pressure sensitive adhesive.
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBenjamin Frye, MD
West Virginia University Department of Orthopaedics
Outcome results
None listed