跳至主要内容
临床试验/NCT05692986
NCT05692986撤回不适用

Randomized Control Trial: Chlorhexidine vs Povidone Iodine Vaginal Prep in Decreasing Postoperative Infection in Total Laparoscopic Hysterectomy

Henry Ford Health System0 个研究点开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
The number of positive cultures in each arm will be compared.

研究概览

简要总结

This is a randomized control trial which will randomize patients who will be undergoing laparoscopic (conventional or robotic assisted) total hysterectomy to vaginal prep with 4% chlorhexidine gluconate vs 10% povidone iodine. There is paucity of information regarding the superiority of one over the other.

详细描述

This is a randomized control trial. During surgery, preoperative vaginal prep is routinely done for hysterectomies. This can be completed with 10% povidone iodine or with 4% chlorhexidine preparation. This study will investigate whether the routine use of betadine vaginal prep in comparison to chlorhexidine prep is superior. Patients will be informed of the study at the time of their preoperative visit in the gynecology clinic at time of surgical scheduling. The attached informed consent sheet will be given to the patient for their signature. The patients will be randomized to receive either 10% povidone iodine or with 4% chlorhexidine vaginal preparation solution. This is not anticipated to take extra time or resources in the operating room setting because the surgical vaginal preparation solutions are typically readily available in the operating room setting. The patients will be assigned an envelope when they are in clinic after they have signed the consent form and that will be the group they are randomized to.

Once the patients are randomized, it is anticipated that 50 patients will be enrolled in each study arm. Following randomization patients will receive the vaginal preparation per the randomization assignment. The patient will be blinded to the study arm. The provider will not be blinded. Follow-up will occur on postoperative day #1 by phone call, and at the 2-week and 6-week follow-up visits.

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 (Participant, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Patients who are scheduled for total laparoscopic hysterectomy

排除标准

  • not able to consent in English or have allergy to the 10% povidone betadine or 4% chlorhexidine solution.

结局指标

主要结局

The number of positive cultures in each arm will be compared.

时间窗: before antibiotic administration, 30 minutes after vaginal prep and q1hr thereafter until the surgery was completed

The number of positive cultures in each arm will be assessed using vaginal swabs to look for contaminated specimens. Positive cultures will be defined as colony forming counts of \>5000cfu, and these will be compared in each arm to determine which preparation is more effective

次要结局

未报告次要终点

研究者

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

Joelle Abood

Principal Investigator

Henry Ford Health System

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