跳至主要内容
临床试验/NCT01378832
NCT01378832已完成3 期

Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Infection in Elective Surgery

Universidad Miguel Hernandez de Elche0 个研究点目标入组 102 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
102
主要终点
Surgical site infection

研究概览

简要总结

Intrabdominal antibiotic irrigation will reduce wound and intrabdominal infection.

详细描述

A prospective, randomized study was performed between January and December 2010. Patient inclusion criteria were a diagnosis of colorectal neoplasms and plans to undergo an elective curative surgery. Patients were divided into 2 groups: Group 1 (intra-abdominal irrigation with normal saline) and Group 2 (intraperitoneal irrigation with a solution of 240 mg gentamicin and 600 mg clindamycin). The occurrence of wound infections and intra-abdominal abscesses were investigated. Following the anastomosis, a microbiological sample of the peritoneal surface was obtained (sample 1). A second sample was collected following an irrigation with normal saline (sample 2). Finally, the peritoneal cavity was irrigated with a gentamicin-clindamycin solution and a third sample was obtained (sample 3).

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

性别
All
接受健康志愿者

入选标准

  • diagnosis of colorectal neoplasms and plans to undergo an elective surgery with curative aims.

排除标准

  • preoperative diagnosis of chronic renal failure, because of the risk of nephrotoxicity associated with intraperitoneal gentamicin absorption
  • an anastomotic leak in the postoperative course

结局指标

主要结局

Surgical site infection

时间窗: 30 days

Intra-abdominal abscess and wound infection will be investigated during the first 30 days after colorectal surgery

次要结局

未报告次要终点

研究者

申办方类型
Other

相似试验

Effect of Peritoneal Lavage With... | 临床试验