Chlorhexidine Gluconate Versus Povidone-iodine (CHDvPI)

December 1, 2020 updated by: Gabriella Smith, University of Arizona

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 87 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative abundances of vaginal microbiota species
Time Frame: 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
From date of surgery to 3-6 weeks postoperative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in level of genital cytokines and chemokines
Time Frame: From date of surgery to 3-6 weeks post-operative
To measure the change in levels of genital cytokines and chemokines (IL-1alpha, IL-1beta, IL-8, MIP-1beta, MIP-3alpha, RANTES, TNFalpha) in the collected cervicovaginal lavages using multiplex cytometric bead arrays after treatment with chlorhexidine gluconate or a povidone-iodine vaginal cleansing solution. The cytokine levels will be used to determine the genital inflammatory score by using a previously described genital inflammation scoring system. Patients will be assigned one point for each mediator when the level was in the upper quartile
From date of surgery to 3-6 weeks post-operative
Change in vaginal pH level
Time Frame: From date of surgery to 3-6weeks post-operative
To measure the change vaginal pH after treatment with chlorhexidine gluconate or a povidone-iodine vaginal cleansing solution.
From date of surgery to 3-6weeks post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Investigators

  • Study Chair: Mike Foley, MD, Banner University Medical Center - Phoenix/ University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 15, 2020

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

September 23, 2020

First Submitted That Met QC Criteria

December 1, 2020

First Posted (Actual)

December 8, 2020

Study Record Updates

Last Update Posted (Actual)

December 8, 2020

Last Update Submitted That Met QC Criteria

December 1, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008991024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vaginal Flora Imbalance

Clinical Trials on Povidone-iodine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe