Prospective, Randomized, Comparative Study About Effects of Preventive Negative Pressure Therapy With PICO or Standard Care Dressing (MEPORE) on Surgical Wounds After Large Incisional Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- questionnaire
研究概览
简要总结
To determine the efficacy on decreasing the rate of surgical wound complications in patients undergoing repair of large incisional hernias, after the prophylactic application of a single-use negative pressure therapy dressing (PICO), versus a conventional dressing.
详细描述
Hypothesis The preventive use of single-use PICO dressing reduces the complications of the surgical wound (infection and dehiscence of the surgical wound) in patients after large incisional hernia repair.
Objectives
Primary:
To determine the efficacy on decreasing the rate of surgical wound complications in patients undergoing eventration surgery, after the prophylactic application of a single-use negative pressure therapy (NPT) dressing, as opposed to a conventional dressing.
Secondary:
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
- Single (Participant)
盲法说明
intraoperative use of randomized dressing
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
- 是
入选标准
- •Patients over 18 years old (men and women).
- •To give his consent to participation in the study.
- •To have surgical prosthetic repair of large incisional hernia (type W2 or W3).
- •Patients admitted to the 6th floor, G tower (Unit of Abdominal Wall surgery).
排除标准
- •Patients with immediate reintervention of abdominal surgery (less than 30 days from the first surgery).
- •Patients after emergency surgery.
- •Patients with biological prosthesis.
- •Pregnancy and lactation.
- •Hepatic cirrhosis.
结局指标
主要结局
questionnaire
时间窗: 1 YEAR
data about surgical site occurrences
次要结局
未报告次要终点
研究者
JOSE BUENO-LLEDÓ
HEAD OF SECTION
Hospital Universitario La Fe