Usefulness of Negative Pressure Therapy After Mesh Removal Due to Chronic Infection: a Multicentric, Prospective, Randomized Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 94
- 主要终点
- Surgical site infection
研究概览
简要总结
Chronic mesh infection mesh is a complication with leads to a long hospital stays, reoperation and admissions through emergency department. Surgical site infection (SSI) after removal are 58-72.7% depending on the published series. New therapeutic lines are needed in order to improve outcomes after surgery such as negative pressure therapy.
The main objective is to determine the SSI differences depending on the use of negative pressure therapy after infected mesh removal.
Material and methods: multicentric, prospective, randomized and an open comparative study. Patients will be selected sequentially n=94. Each selected patient will be randomized in two groups: conventional closure of the surgical wound vs. negative pressure therapy with a 30-day follow-up.
详细描述
The surgeon will not know the patient's arm of study before the operation. Once the wound will be closed, we will let know what kind of closure the patient will need. Negative pressure therapy will be the same in all patients, in order to mantain homogeneity.
We will set appointments each day while he is hospitalized, and after the discharge: at 7 (+/- 1) and 30 (+/- 5).
We will collect demographic data before and during surgery, as well as in the postoperative period, including appointments.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any gender, adult. Age minimum limits
- •Infected chronic mesh.
- •Signing of informed consent.
排除标准
- •Enterocutaneous fistula or enteroatmospheric fistula.
- •Infected chronic mesh related to parastomal hernia.
- •Patients who will no complete the follow-up period.
- •Informed consent denial.
结局指标
主要结局
Surgical site infection
时间窗: 30 days
Differences between surgical site infection between conventional closure vs negative pressure therapy
次要结局
未报告次要终点