Comparison of the Risk of Surgical Site Infections Between Dressings Stopped at Postoperative Day 1 vs Dressings Stopped at Postoperative Day 6+/-1 After Elective Abdominal Surgery: a Multicentre Non-inferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,288
- 试验地点
- 1
- 主要终点
- Proportion of superficial surgical site infections (SSI)
研究概览
简要总结
The daily changing of postoperative dressings is a widespread practice, often continuing until the 5th-7th day after surgery. In theory, dressings aim to reduce the risk of superficial surgical site infections (SSIs). However, several studies have suggested that early removal of the dressing does not significantly impact the rate of superficial SSIs, and this approach is now applied in clinical practice by several teams. A Cochrane review indicated that the absence of dressing does not appear to be harmful, though it emphasized the very low level of evidence provided and the need for high-quality randomized controlled trials. In this study, the investigators aim to provide high-level evidence on the effect of stopping dressings from the 1st postoperative day and the lack of impact on the risk of SSIs, to standardize practices and enable recommendations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Patient of legal age (≥18 years)
- •Scheduled for elective abdominal surgery requiring a skin incision of at least 4 cm long listed below:
- •All pancreatectomies, All hepatectomies, All splenectomies, All adrenalectomies, All bariatric surgeries, All gastric surgeries, including gastrectomy and reflux surgery, All parietal surgeries; ventral hernia repairs, inguinal or femoral hernia repairs, with or without mesh placement..
- •All small bowel resections, Laparotomy cholecystectomies, All duodenal surgeries, Right, transverse or left colectomy, by laparotomy or laparoscopy, provided that there is a skin incision for extraction of the surgical specimen, but without the presence or creation of a stoma Proctectomy but without the presence or creation of a stoma
- •Class I or II (clean or clean-contaminated) according to the ALTEMEIER classification
- •Affiliated in a Social Security scheme (beneficiary or entitled person, excluding AME)
- •Have signed an informed consent form
排除标准
- •Presence or completion of a stoma
- •Previous abdominal surgery in the month prior to inclusion
- •Emergency surgery
- •Outpatient surgery
- •Closure by biological glue
- •Active bacterial infection at the time of surgery or recent antibiotic therapy (up to 15 days before surgery)
- •Neutrophil count < 500/mm3 at time of surgery
- •Grade B or C cirrhosis (Child-Pugh classification)
- •Pregnancy
- •Breast-feeding
- •Patient under guardianship or curatorship
- •Patient deprived of liberty by judicial or administrative decision
- •Patient unable to perform perioperative care
结局指标
主要结局
Proportion of superficial surgical site infections (SSI)
时间窗: Day 30 post-surgery
The percentage of superficial surgical site infections (SSI) within the 30 days following surgery, defined according to the criteria set by the Centers for Disease Control and Prevention (CDC).
次要结局
- Rate of repeat surgery(30 days post-surgery)
- Overall morbidity rate according to Clavien-Dindo(30 days post-surgery)
- Rate of antibiotic treatment(30 days post-surgery)
- Rate of unscheduled nursing care(30 days post-surgery)
- Percentage of patients who asked for their scars to be covered(30 days post-surgery)
- The incremental cost-effectiveness ratio (ICER)(30 days after inclusion)
- Direct and indirect costs(Day 30 post-surgery)
- Total length of hospital stay(30 days post-surgery)
- Quality of life for patients(Day 6 and Day 30 post-surgery)
- The incremental cost-utility ratio (ICUR)(30 days after inclusion)