Chlorhexidine Gluconate Versus Povidone-iodine

Not Applicable

• Conditions: Vaginal Flora Imbalance
• Interventions: Other: Povidone-iodine; Other: Chlorhexidine Gluconate

• Registration Number: NCT04658355
• Lead Sponsor: University of Arizona

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-09-23
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-01
• Last Update Submitted: 2020-12-01
• Study First Posted: 2020-12-08
• Last Update Posted: 2020-12-08
• Study Start: 2020-12-15
• Primary Completion: 2021-08
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Povidone-Iodine	Povidone-iodine	Povidone-iodine to be used as the cleansing solution in this arm of patients for surgical vaginal preparation.
Chlorhexidine Gluconate	Chlorhexidine Gluconate	Chlorhexidine gluconate to be used as the cleansing solution in this arm of patients for surgical vaginal preparation.

Primary Outcome Measures

Name	Time	Method
Frequency of patient-reported vaginal and urinary symptoms after treatment with chlorhexidine gluconate or povidone-iodine vaginal cleansing solution	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.

Secondary Outcome Measures

Name	Time	Method
Relative abundances of vaginal microbiota species	From date of surgery to 3-6 weeks postoperative	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