NCT02664168Unknown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
干预措施
试验速览
- 阶段
- 不适用
- 试验地点
- 2
- 主要终点
- Incidence of Surgical Site Infection
研究概览
简要总结
The aim of this study is to assess the prevention of incision healing complications in patients undergoing revision TKA and THA treated with either Single-Use NPWT (PICO) compared to standard of care dressings (AQUACEL Ag Surgical Dressing). All patients undergoing a revision TKA and THA who consent to taking part in the study, and meet the eligibility criteria will be included onto the study. Patients will be followed up for a period of up to 3 months to determine if there are any latent incision healing complications
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
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- •Subjects who have participated in this trial previously and who were withdrawn 9 .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)
研究组 & 干预措施
Single-Use Negative Pressure Wound Therapy (PICO)
Active Comparator
干预措施: Single-Use Negative Pressure Wound Therapy (PICO) (Device)
Aquacel Ag Surgical Dressing
Active Comparator
干预措施: Aquacel Ag Surgical Dressing (Device)
结局指标
主要结局
Incidence of Surgical Site Infection
时间窗: 90 days post-op
次要结局
未报告次要终点
研究者
研究点 (2)
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