NCT03180346Unknown不适用
A Prospective, Randomized, Comparative Study to Assess the Prevention of Surgical Site Infection (SSI's) in Revision Total Joint Arthroplasty Patients Treated With Single-Use Negative Pressure Wound Therapy (PICO) or Standard Care Dressings (AQUACEL Ag SURGICAL Dressing).
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 494
- 试验地点
- 2
- 主要终点
- Surgical Site Infection
研究概览
简要总结
The primary aim of this study is to determine if the SSI rate following revision total hip and knee arthroplasty is reduced in patients treated with the PICO device compared to patients with traditional postoperative dressings. Our secondary goals include; comparing the amount of wound drainage, rate of resolution of wound drainage, length of hospital stay, functional outcomes, and economic implications of wound drainage and SSI after revision arthroplasty comparing PICO and traditional dressings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≥18 years old
- •Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
- •Subjects undergoing revision total knee arthroplasty or revision total hip arthroplasty
- •Subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information
- •Subjects deemed able to understand and comply with study visit schedule and procedures
排除标准
- •Wounds that require daily inspection
- •Active bleeding within the surgical site
- •Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception
- •Subjects on warfarin therapy. Resulting in increased exudate and prolonging hospital stay following surgery to achieve therapeutic INR levels
- •Skin integrity issues that preclude the use of Negative Pressure Wound Therapy (NPWT)
- •Subjects undergoing primary total joint procedures
- •Subjects with a known history of poor compliance with medical treatment
- •Subjects who have participated in this trial previously and who were withdrawn 9 . Subjects with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing)
结局指标
主要结局
Surgical Site Infection
时间窗: 90-day followup following revision surgery
次要结局
未报告次要终点
研究者
研究点 (2)
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