Chlorhexidine Gluconate Versus Povidone-iodine

University of Arizona100 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Vaginal Flora Imbalance

Interventions

Chlorhexidine GluconateOTHER

4% Chlorhexidine Gluconate vaginal cleansing solution as a surgical preparation.

Povidone-iodineOTHER

10% povidone-iodine vaginal cleansing solution as a surgical preparation.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

* Inclusion Criteria: 1. Females 2. all races and ethnicities 3. English-speaking 4. pre-menoupausal 5. undergoing gynecologic surgeries requiring vaginal operative preparation at Banner University Medical Center - Phoenix. Exclusion Criteria: 1. Patients with dx of vaginitis or vulvovaginal atrophy at time of surgery 2. Patients with an allergy to povidone-iodine and/or Chlorhexidine Gluconate 3. 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 4. Currently menstruating 5. 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 6. Have a history of or current, self-reported genital herpes 7. Have current or in the past 6 weeks, conditions such as 1. Vaginal infection/bacterial vaginosis/yeast infection or sexually transmitted infection (Chlamydia, Gonorrhea or Trichomonas)/Hepatitis/HIV 2. Vulvar infection 3. Urinary tract infection 8. Sexual intercourse less than 48 hours prior to the visit 9. Current treatment for any skin conditions on the testing area

Outcomes

Primary Outcomes

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.

Time frame: From date of surgery to 24 hours post-operative

Secondary Outcomes

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

Time frame: From date of surgery to 3-6 weeks postoperative

Central Contacts

Elisa Martinez, MBA

CONTACT

480-430-4810 elisamartinez@arizona.edu

Regina Montero, MSN

CONTACT

480-239-8697 rmontero52@arizona.edu

Data from ClinicalTrials.gov

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