跳至主要内容
临床试验/NCT00953784
NCT00953784已完成不适用

Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery

Dallas VA Medical Center2 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2007年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
197
试验地点
2
主要终点
%/type Surgical wound infections rated per infection classifications of NNIS/CDC

研究概览

简要总结

This is a comparison, at this VA Hospital, of standard operating room management in colorectal surgery to a more rigid management using an additional five previously tested treatments to determine if this changes the rate of post operative wound infections.

详细描述

A comparison between standard operating room:

  1. use of pre-op bowel prep (Golytely or Phosphosoda,plus 3 doses of oral antibiotics(Erythromycin and Neomycin), and fleets enema the day before surgery
  2. Standard anesthesia FiO2 (approx. 30-50%)during surgery
  3. Standard IV fluids during surgery(greater than 200cc per hour)
  4. Standard post-op O2 by mask for 2 hours

To extended operating room procedures of:

  1. No po antibiotics or pre-op bowel prep other than enema prior to surgery
  2. Skin warming at least 15 minutes prior to and during surgery(core temp 36C+)
  3. IOBAN drapes and Plastic wound protectors used during surgery
  4. Restricted IV fluids less than 200cc per hour during surgery
  5. Increased FiO2 to 80% during surgery and 2 hours after by mask

Monitoring for post-op wound infections at discharge and up to 30days post-op

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 (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

入选标准

  • Scheduled VA adult elective colorectal surgery patient

排除标准

  • Non VA adults, emergent colorectal surgery, scheduled multiple surgery procedures,pts with other infections being treated

结局指标

主要结局

%/type Surgical wound infections rated per infection classifications of NNIS/CDC

时间窗: with in 30 days post-op

次要结局

  • %/type surgical wound infections per classifications per NNIS/CDC(at hospital discharge)

研究者

申办方类型
Fed

研究点 (2)

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