Efficacy of Negative Pressure Wound Closure Therapy by PICO System in Prevention of Complications of Femoral Artery Exposure
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Hematoma
研究概览
简要总结
Evaluate negative pressure wound closure therapy by PICO system in Prevention of complications of femoral artery exposure.
详细描述
INTRODUCTION:
Wound infection is a very common complication in patients who undergo femoral artery exposure. It can lead to prolonged hospital stays, increased healthcare expenditures, admission times, graft failure, and limb loss and is recognized as a significant cause of postoperative morbidity and mortality.
Negative pressure wound therapy (NPWT) has been developped as a method for reducing the risk of wound complications and is the wound dressing of choice in many vascular procedures during the arterial exposure.
The idea of NPWT is a therapeutic technique wherein subatmospheric pressure is applied to a wound using a sealed wound dressing that is connected to a vacuum pump, which can be continuously or intermittently applied.
The mechanism of NPWT, is that it facilitates wound healing by decreasing the bacterial burden; promoting granulation tissue formation, capillary blood flow, endothelial proliferation, and angiogenesis; and restoring the integrity of the capillary basement membrane.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Block randomization
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All femoral artery exposure whatever the type of surgery
排除标准
- •who can't give consent (unconscious)
- •Those with mental or behavioral disorders
研究组 & 干预措施
Application of the device (PICO)
PICO® is a disposable, single-use pump without a canister that generates an effective, non-adjustable, negative pressure of -80 mmHg and that can be used for up to 7 days.(-1113) It incorporates leak detection and low battery indicators and is connected to a 4-layer absorbent dressing that primarily removes wound exudates through evaporative loss. The mechanism of action has been postulated to occur because of the combined effects of a reduction in the frequency of dressing changes, a reduction in stress concentration in the tissue surrounding the incision, and an enhancement in the appositional strength of the incision line, thus reducing dead space and minimizing the risk of wound contamination.(14) PICO® has also been demonstrated to enhance lymphatic clearance and decrease the risk of hematomas or seromas
干预措施: Femoral Wound Closure and dressing (Procedure)
Conventional Dressing of the femoral wound
Conventional Dressing of the femoral wound
结局指标
主要结局
Hematoma
时间窗: 12 months
Blood collected under the suture line
Infection
时间窗: 12 months
Clinical( fever, collection) and Radiological
seroma
时间窗: 12 months
Fluid collected under the suture line
次要结局
- Wound Dehiscence(12 Months)