Effect of Chlorhexidine Gluconate Versus Povidone-iodine on the Vaginal Microbiome as Vaginal Operative Preparation During Gynecologic Surgeries
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Frequency of patient-reported vaginal and urinary symptoms after treatment with chlorhexidine gluconate or povidone-iodine vaginal cleansing solution
研究概览
简要总结
A hysterectomy, or removal of the uterus, is a common surgery performed for a variety of reasons. During this surgery, to prevent infection, the vagina is thoroughly prepped with a cleansing solution, most commonly chlorhexidine gluconate or povidone-iodine. While studies have shown that chlorhexidine gluconate is better at killing bacteria people have raised concerns on how it affects the vaginal tissue. It is important to study these effects the cleansing solution surgeons use for this surgery can not only prevent infection but not cause harmful side effects.
详细描述
The purpose of this study is to examine the effects of different vaginal operative preparations on the vaginal tissue and microbiome. Our primary working hypothesis is that chlorhexidine prep is more deleterious to vaginal tissue than povidone-iodine preparations.
Hypothesis 1: chlorhexidine gluconate is more disruptive to the vaginal microbiome than povidone-iodine Hypothesis 2: chlorhexidine gluconate leads to more vaginal atrophy than povidone-iodine
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •all races and ethnicities
- •English-speaking
- •pre-menoupausal
- •undergoing gynecologic surgeries requiring vaginal operative preparation at Banner University Medical Center - Phoenix.
排除标准
- •Patients with dx of vaginitis or vulvovaginal atrophy at time of surgery
- •Patients with an allergy to povidone-iodine and/or Chlorhexidine Gluconate
- •Individuals with any skin conditions, as determined by the physician, which could interfere with the conduct of the study or increase the risks to the test subject including any open or healing cuts/incisions, abrasions, or broken skin in the testing area as determined by the physician
- •Currently menstruating
- •Be using or have used antibiotics, antifungals, topical steroids or antiviral (oral or topical in the testing areas) less than 12 weeks prior to visit
- •Have a history of or current, self-reported genital herpes
- •Have current or in the past 6 weeks, conditions such as
- •Vaginal infection/bacterial vaginosis/yeast infection or sexually transmitted infection (Chlamydia, Gonorrhea or Trichomonas)/Hepatitis/HIV
- •Vulvar infection
- •Urinary tract infection
- •Sexual intercourse less than 48 hours prior to the visit
- •Current treatment for any skin conditions on the testing area
结局指标
主要结局
Frequency of patient-reported vaginal and urinary symptoms after treatment with chlorhexidine gluconate or povidone-iodine vaginal cleansing solution
时间窗: From date of surgery to 24 hours post-operative
To compare the frequency of patient-reported vaginal and urinary symptoms after treatment with chlorhexidine gluconate or povidone-iodine vaginal cleansing solution utilizing questionnaires.
次要结局
- Relative abundances of vaginal microbiota species(From date of surgery to 3-6 weeks postoperative)
研究者
Gabriella Smith
Resident Physician
University of Arizona