Evaluation of the Effectiveness of a Closed-incision Negative-pressure Therapy (Prevena®) on Bilateral Groin Incision
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Wound aspect - major complication
研究概览
简要总结
Closed-incision negative-pressure therapy are medical device that are suspected to reduce groin wound complication in vascular surgery. The aim of this study is to compareon on the same patient a Closed-incision negative-pressure therapy (Prevena®, KCI) versus a traditional gauze dressings after a bilateral vascular groin surgery. To do this, each device is applied on one groin incision and the side, left or right, is randomized.
详细描述
The prevalence of surgical site infections in groin vascular surgery is 3-44%. The factors causing these infections are well identified: disruption of lymphatic vessels, proximity of genital organs, presence of prosthetic material, etc. The risk of developing an infection of the surgical site is also influenced by the patient's comorbidities and by the surgical context.
Closed-incision negative-pressure therapy are medical device that are suspected to reduce groin wound complication in vascular surgery. The mechanisms of action for negative-pressure therapy include protecting the wound bed, splinting soft tissue, reducing oedema,increasing perfusion and enhancing development of granulation tissue.
Presently, there are no guidelines for the use of this device or not in groin incision and this decision is left to the surgeon's discretion.
The main objective is to demonstrate the superiority of closed-incision negative-pressure therapy over the application of a traditional gauze dressings to reduce the rate of major complications (i.e. requiring an extension of hospitalization time) during bilateral vascular groin surgery. To do this, each device is applied on one groin incision and the side, left or right, is randomized.
The secondary objectives are:
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
- 否
入选标准
- •Person affiliated to a health insurance system
- •Person who has received full information on the organization of the research and has signed his or her informed consent
- •Person presenting a bilateral vascular groin surgery
- •Major person
排除标准
- •Person with a known allergy to one of the components of the evaluated product (including: acrylic or silver-based adhesives)
- •Person with a contraindication to the product(s) being evaluated
- •Non-collaborative or agitated patient
- •Patients with hemostasis problems
- •Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code:
- •Pregnant woman, parturient or breastfeeding mother
- •Minor person (not emancipated)
- •Adult person subject to a legal protection measure (guardianship, curatorship, protection of justice)
- •Adult person unable to consent
- •Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1.
结局指标
主要结局
Wound aspect - major complication
时间窗: 4 days
Left and right wound incision are inspected and the presence of major complication are reported. Major complication : Presence of pus Bloody and/or lymphatic discharge Disunity Necrosis
次要结局
- Major complication in different clinical settings(4-days)
- Score of complications(4-days)
- Wound aspect - major complication (long term)(2-3 months)