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临床试验/NCT00528008
NCT00528008终止3 期

Povidone-iodine vs. Chlorhexidine Gluconate - A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections

Memorial University of Newfoundland2 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2007年12月最近更新:
适应症

试验速览

阶段
3 期
状态
终止
入组人数
268
试验地点
2
主要终点
to determine the rate of wound infection using two standard wound preparations: povidone-iodine and chlorhexidine gluconate

研究概览

简要总结

The purpose of this study is to find out if chlorhexidine gluconate solution is better at reducing the rate of wound infection after cesarean section compared to povidone-iodine.

详细描述

Wound infection is a universal potential morbidity to any type of surgery. Over the years many studies have been completed to evaluate ways to decrease this morbidity. Recent literature has looked at different types of surgical solutions used in pre-operative cleansing. Chlorhexidine and povidone-iodine are two standard surgical prep solutions used on a global scale. The most recent literature has shown that chlorhexidine has a decreased wound infection rate for longer surgeries. Cesarean section, as a surgical time, varies from 20 - 60 minutes. There has been no known literature regarding wound infection rates using these two solutions in elective cesarean sections. This trial will review the rates of wound infection using chlorhexidine and povidone-iodine during elective cesarean section and determine if there is any statistically significant difference between the two solutions. The results could potentially decrease wound infection rates, decrease morbidity, decrease hospital length of stay, and help to guide further surgical management.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age >19 years
  • Gestational age > 37 weeks
  • Booked elective cesarean section

排除标准

  • Gestational age < 37 weeks
  • Premature rupture of membranes
  • Onset of labor prior to procedure
  • Evidence of maternal sepsis; maternal fever > 38.5C
  • LSCS for emergency issues: non-reassuring fetal status, placental abruption, failed induction

结局指标

主要结局

to determine the rate of wound infection using two standard wound preparations: povidone-iodine and chlorhexidine gluconate

时间窗: within 6 weeks following surgery

次要结局

  • readmission to hospital(within 6 weeks following surgery)
  • extended length of admission(within 6 weeks following surgery)
  • need for intravenous antibiotics(within 6 weeks following surgery)
  • need for repeat procedure such as drainage(within 6 weeks following surgery)
  • increased outpatient surveillance(within 6 weeks following surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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