Effect of Intraperitoneal Irrigation With Antibiotic Solution, Triclosan-impregnated Sutures for Fascial Closure and Mupirocin Ointment Over the Skin Staples, on Surgical-site Infection After Laparoscopic Colorectal Surgery
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Incisional surgical site infection
研究概览
简要总结
A prospective randomized clinical trial will be performed. Patients will be randomized in 2 groups. The experimental group will undergo the combined application of intraperitoneal irrigation with clindamycin and gentamicin solution, fascial closure with Triclosan-impregnated sutures and application of mupirocin ointment over the skin staples, in addition to the standard care measures. The control group undergo only the standard care measures.
Incisional surgical-site infection will be investigated.
详细描述
A prospective randomized clinical trial will be performed. Patients will be randomized in 2 groups. The experimental group will undergo the combined application of intraperitoneal irrigation with clindamycin (600mg) and gentamicin (240 mg) solution in 250 ml of normal saline, fascial closure with Triclosan-impregnated polyglactin suture and application of mupirocin ointment over the skin staples, in addition to the standard care measures. The control group undergo only the standard care measures, including decontamination of the skin during surgery with chlorhexidine alcohol solution, administration of systemic antibiotic prophylaxis and application of thermal blanket to avoid hypothermia. In the control group, the fascial closure will be performed with a polyglactin suture (without Triclosan impregnation).
Incisional surgical-site infection will be investigated.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The election of the intervention will be performed following a randomization model. Only the care provider will know the assigned group.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with colorectal cancer undergoing elective laparoscopic colorectal surgery with curative aims.
排除标准
- •Chronic renal failure
- •Immunodeficiency status, including uncontrolled Type 2 diabetes mellitus and patients under corticoid or immunosuppresive treatment
研究组 & 干预措施
Bundle application
The patients in this group will undergo an intraperitoneal irrigation with clindamycin and gentamicin solution, fascial closure with triclosan impregnated sutures and application of Mupirocin ointment over the skin staples
干预措施: Bundle (Drug)
Bundle application
The patients in this group will undergo an intraperitoneal irrigation with clindamycin and gentamicin solution, fascial closure with triclosan impregnated sutures and application of Mupirocin ointment over the skin staples
干预措施: Standard care (Procedure)
Standard care
The patients in this group will follow a standard care, including decontamination of the skin during surgery with chlorhexidine alcohol solution, administration of systemic antibiotic prophylaxis and application of thermal blanket to avoid hypothermia. In the standard care, the fascial closure will be performed with a polyglactin suture (without Triclosan impregnation).
干预措施: Standard care (Procedure)
结局指标
主要结局
Incisional surgical site infection
时间窗: 30 days postoperatively
Incisional surgical site infection will be evaluated up to the 30th postoperative day by an epidemiology nurse.
次要结局
未报告次要终点
研究者
Jaime Ruiz-Tovar, MD, PhD
Principal Investigator
Hospital General Universitario Elche