Rate of Allergic Contact Dermatitis and Cosmetic Outcomes for Three Wound Closure Techniques in Joint Arthroplasty Patients: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Rate of allergic contact dermatitis (4 Days Post Op)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Exofin Skin Glue
Topical Wound Closure to be applied once the deep wound closure is secured after Total Knee or Total Hip Arthroplasty
干预措施: Exofin Skin Glue (Procedure)
Sylke Adhesive Dressing
Topical Wound Closure to be applied once the deep wound closure is secured after Total Knee or Total Hip Arthroplasty
干预措施: Sylke Adhesive Dressing (Procedure)
Suture Strip Plus
Topical Wound Closure to be applied once the deep wound closure is secured after Total Knee or Total Hip Arthroplasty
干预措施: Suture Strip Plus (Procedure)
结局指标
主要结局
Rate of allergic contact dermatitis (4 Days Post Op)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Difference in Cosmetic Outcome (4 Days Post-Op)(4 Days Post-Op)
- Difference in Cosmetic Outcome (2 Weeks Post-Op)(2 Weeks Post-Op)
- Difference in Cosmetic Outcome (6 Weeks Post-Op)(6 Weeks Post-Op)
- Difference in Cosmetic Outcome (3 Months Post-Op)(3 Months Post-Op)
研究者
Benjamin Frye
Associate Professor, Fellowship Director Adult Reconstruction
West Virginia University