Chlorhexidine Gluconate Versus Povidone-iodine

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effect of Chlorhexidine Gluconate Versus Povidone-iodine on the Vaginal Microbiome as Vaginal Operative Preparation During Gynecologic Surgeries

Conditions
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Vaginal Flora Imbalance

Intervention / Treatment
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* Other: Chlorhexidine Gluconate
* Other: Povidone-iodine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females all races and ethnicities English-speaking pre-menoupausal undergoing gynecologic surgeries requiring vaginal operative preparation at Banner University Medical Center - Phoenix. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Chlorhexidine Gluconate vs Povidone-iodine group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Povidone-Iodine<br>Povidone-iodine to be used as the cleansing solution in this arm of patients for surgical vaginal preparation. | Other: Povidone-iodine<br>* 10% povidone-iodine vaginal cleansing solution as a surgical preparation.<br>|
| Experimental: Chlorhexidine Gluconate<br>Chlorhexidine gluconate to be used as the cleansing solution in this arm of patients for surgical vaginal preparation. | Other: Chlorhexidine Gluconate<br>* 4% Chlorhexidine Gluconate vaginal cleansing solution as a surgical preparation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of patient-reported vaginal and urinary symptoms after treatment with chlorhexidine gluconate or povidone-iodine vaginal cleansing solution | To compare the frequency of patient-reported vaginal and urinary symptoms after treatment with chlorhexidine gluconate or povidone-iodine vaginal cleansing solution utilizing questionnaires. | From date of surgery to 24 hours post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative abundances of vaginal microbiota species | To measure the change in relative abundances of vaginal microbiota species after treatment with chlorhexidine gluconate or a povidone-iodine vaginal cleansing solution. Vaginal microbiota species include but not limited to health-associated Lactobacillus spp., bacterial-vaginosis associated anaerobes (Gardnerella, Prevotella, Sneathia, Atopobium, Megasphaera, Parvimonas, Mobiluncus and others), pathobionts (Streptococcus, Escherichia), and other bacterial taxa present in the collected vaginal swabs using 16S rRNA sequencing | From date of surgery to 3-6 weeks postoperative |