NCT04520841Unknown不适用
Monocentric Randomized Clinical Trial Comparing Negative Pressure Wound Therapy (PREVENA™) and Standard Dry Dressings on Oozing of Closed Incision After Revision Total Hip and Knee Arthroplasty Surgery or Lower Extremity Amputation Surgery
University of Lausanne Hospitals2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Discharge after 7 days
研究概览
简要总结
Negative pressure dressings are currently widely used in wound management. Their use is gradually being extended to surgical scars. However, studies demonstrating a clear benefit are rare, particularly in terms of postoperative discharge, the need for surgical revision due to prolonged oozing and cost.
The aim of this study is to evaluate the benefit of such a device in post-operative revision prosthesis surgery (hip and knee), as well as lower limb amputations.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Age ≥ 18 years old
- •Planned Surgery :
- •revision of a hip or knee prosthesis, in 1 or 2 stages, at explantation and/or reimplantation, where
- •elective amputation of a lower limb (transmetatarsal, trans-tibial (Burgess) or trans-femoral (Gritti-Stokes) level (nb: patients for whom amputation of both lower limbs is planned will be excluded)
排除标准
- •Known allergy to dry dressings
- •Patient already included in another clinical trial
- •Inability to discern and/or inability to follow study procedures
- •Known allergy to silver or another component of the system Prevena™
- •Amputation for tumor pathology
结局指标
主要结局
Discharge after 7 days
时间窗: Day 7- Day 8
Presence of discharge at 7 days postoperatively (Day 7) Condition of the dry dressing applied on Day 7 and evaluated at least 24 hours after application (Day 8)
次要结局
- Revision surgery(Day 0 - Day 14)
- Hospitalisation(Day 0 - Day 14)
- Complications(Day 0 - Day 14)
- Patient satisfaction(Day 7)
- AE & ADE(Day 0 - Day 14)
- Costs(Day 0 - Day 7)
研究者
Sylvain Steinmetz
Principal Investigator
University of Lausanne Hospitals
研究点 (2)
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