NCT01258270已完成不适用
Efficacy and Patient Satisfaction With AQUACEL® Ag Surgical Dressing Compared to Standard Surgical Dressing. A Prospective, Randomized Study in Primary Total Joint Arthroplasty.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- The incidence of postoperative severe skin reactions (defined as blisters) around the surgical incision site
研究概览
简要总结
The objective of this study is to determine the safety and effectiveness of the AQUACEL® Ag Surgical Dressing (treatment group) as compared to prepackaged island wound dressings consisting of traditional tape and gauze (control group) for total hip and total knee arthroplasty.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting for primary total hip performed through a posterior or posterior-lateral surgical approach or primary total knee arthroplasty
- •Patients between the ages of 18 and 90
- •The subject is willing and able to understand, sign and date the study specific patient Informed Consent, to volunteer participation in the study
- •The subject is having surgery at a Carolinas HealthCare System facility
- •The subject is psychosocially, mentally and physically able to comply with the requirements of the study
排除标准
- •Patients presenting for revision total hip or total knee arthroplasty
- •Patients with topical hypersensitivity or allergy to any disposable components of the dressing system such as: ionic silver, polyurethane film
- •Any systemic or local active dermatological disease that might interfere with the evaluation of the surgical site such as eczema, psoriasis, skin cancer, scleroderma, chronic urticaria
- •Patients currently participating in another clinical trial that may affect your participation in this trial
- •Patients with insurance coverage not included in Gentiva list of payers
- •Patients residing outside of Gentiva's geographical coverage area
- •Patients having surgery at a NON-Carolinas HealthCare System facility
结局指标
主要结局
The incidence of postoperative severe skin reactions (defined as blisters) around the surgical incision site
时间窗: 4 weeks postop
Wound checks will be performed during the postoperative period in the hospital followed by home healthcare providers. The final wound check will be performed by the surgeon at 4 weeks postoperatively.
次要结局
- Patient pain and satisfaction (1-100 visual analog scale)(immediate postop, 5-7 days postop, 4 weeks postop)
研究者
研究点 (2)
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