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临床试验/NCT04202471
NCT04202471撤回不适用

Preoperative Chlorhexidine Cloths to Reduce Surgical Site Infection in Non-Scheduled Cesarean Deliveries

Northwell Health2 个研究点 分布在 1 个国家开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Rate of surgical site infection

研究概览

简要总结

Pregnancy-associated infection represents a major cause of maternal morbidity and mortality. Cesarean delivery is the most common major surgical procedure and is associated with a rate of surgical site infection (SSI) that is approximately 5-10 times the rate for vaginal delivery. Efforts to reduce the risk of SSIs in this patient population include the use of preoperative antibiotic prophylaxis in addition to skin and vaginal antiseptic preparations.Nevertheless, the rate of SSI in women undergoing non-scheduled cesarean delivery is up to 18%, a significant number that contributes to prolonged hospital stays and increased health care costs.

Every effort should be made to reduce this major cause of pregnancy-associated morbidity and mortality to aid in the care of patients and reduce the associated prolonged hospital stays, readmission rates and health care costs. Studies have shown that preoperative application of chlorhexidine cloths reduces the risk of SSI, however this is based on literature in the orthopedic and intensive care patients. The efficacy of this intervention has not been studied in obstetric patients undergoing cesarean delivery. Furthermore, obstetric patients undergoing non-scheduled cesarean delivery represent a target population as it is thought that infectious morbidity is higher in this patient population. Therefore, there is a need for this trial to determine if this intervention is effective in reducing the rate of postoperative SSIs.

详细描述

This randomized clinical trial will be investigating the use of preoperative chlorhexidine cloths, a chemical skin antiseptic agent effective on gram positive and gram negative bacteria, as an intervention to reduce the rate of surgical site infections (SSIs). The intervention group will be women undergoing non-scheduled cesarean delivery randomized to receive preoperative abdominal application of 2% chlorhexidine cloths. The control group will be women undergoing non-scheduled cesarean delivery randomized to receive standard preoperative care. The impact on women's health is significant, as a reduction in SSIs in this prevalent patient population can reduce the number of prolonged hospital stays, outpatient follow-ups for infection, hospital readmissions and health care costs.

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
Double (Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • undergoing non-scheduled cesarean delivery > 23 weeks gestation

排除标准

  • allergy to chlorhexidine, emergency cesarean delivery, evidence of infection at operative site

结局指标

主要结局

Rate of surgical site infection

时间窗: Up to 6 weeks after cesarean delivery

次要结局

  • Hospital length of stay(Up to 6 weeks after cesarean delivery)
  • Number of office visits(Up to 6 weeks after cesarean delivery)
  • Number of hospital readmissions for infection-related complications(Up to 6 weeks after cesarean delivery)
  • Rate of endometritis(Up to 6 weeks after cesarean delivery)
  • Rate of positive wound culture from wound(Up to 6 weeks after cesarean delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Moti Gulersen

Principal Investigator

Northwell Health

研究点 (2)

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