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临床试验/NCT03412734
NCT03412734终止4 期

Is Chlorhexidine Vaginal Preparation Prior to Hysterectomy Superior to Iodine in Reducing Bacterial Count; a Randomized Controlled Trial

TriHealth Inc.1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2018年5月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
94
试验地点
1
主要终点
Number of Participants With Contamination

研究概览

简要总结

This is a randomized controlled trial to determine the influence of chlorhexidine gluconate surgical/topical antiseptic solutions on the bacterial environment of the vagina during hysterectomy and compare that to the effect of standard iodine-based preparations on the same.

详细描述

Postoperative infection remains the most common complication of surgical procedures in gynecology. Historically, 30-40% of patients undergoing a hysterectomy develop a post-operative infection. The initiation of antibiotic prophylaxis for appropriate surgical procedures was a significant advancement in the prevention of surgical site infection.

Antibiotic prophylaxis has been standardized and universally implemented. A remaining variable is the method of aseptic preparation of the vagina with substantial variation of technique being reported even within institutions.

The most recent Committee Opinion by the American College of Obstetricians and Gynecologists concludes there is insufficient evidence to render a strong recommendation for either povidone-iodine or chlorhexidine as the ideal agent for surgical preparation of the vagina and that further evidence is necessary.

Povidone-iodine solution has been considered the standard for aseptic surgical preparation of the vagina for decades and is the only solution approved by the FDA for vaginal use. There are however specific qualities of the solution that suggest it may be less than ideal for use in the vagina. More contemporary efforts have begun to focus on chlorhexidine as a more ideal agent for aseptic efforts in surgical preparation of the vagina.

The purpose of our study is to use a randomized controlled trial to determine if chlorhexidine gluconate surgical preparation maintains a lower rate of contamination to the surgical field.

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

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

入选标准

  • Undergoing total vaginal, laparoscopic assisted vaginal, total laparoscopic, or robotic-assisted laparoscopic hysterectomy by a physician at Cincinnati Urogynecology Associates or Tri-State Gynecology Oncology TriHealth Inc.
  • Concomitant procedures such as vaginal vault suspension, suburethral sling, cystoscopy, enterocele repair, anterior or posterior colporrhaphy, bilateral salpingectomy or salpingooophorectomy, staging procedures, lymph node sampling and other indicated procedures will be included
  • English speaking
  • Ability to provide consent

排除标准

  • Unwillingness to participate in the study
  • Non English speaking
  • Patients that do not undergo a hysterectomy
  • Reported allergy to iodine or chlorhexidine preparation solutions
  • Patients undergoing planned debulking surgery for ovarian, fallopian tube or primary peritoneal cancers
  • Current infection necessitating hysterectomy
  • Active sepsis, pelvic abscess or pelvic inflammatory disease

研究组 & 干预措施

Iodine group

Active Comparator

干预措施: Iodine (Drug)

Chlorhexidine group

Experimental

干预措施: Chlorhexidine (Drug)

结局指标

主要结局

Number of Participants With Contamination

时间窗: 90 minutes from initial preparation

Contamination is defined as having \>5000 bacteria within a culture

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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