Chlorhexidine Gluconate Versus Povidone-iodine (CHDvPI)

University of Arizona

Status: Unknown

Conditions: Vaginal Flora Imbalance

Treatments: Other: Chlorhexidine Gluconate; Other: Povidone-iodine

Study type: Interventional

Funder types: Other

Identifiers

NCT04658355

2008991024

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Povidone-Iodine

Active Comparator group

Description:

Povidone-iodine to be used as the cleansing solution in this arm of patients for surgical vaginal preparation.

Treatment:

Other: Povidone-iodine

Chlorhexidine Gluconate

Experimental group

Description:

Chlorhexidine gluconate to be used as the cleansing solution in this arm of patients for surgical vaginal preparation.

Treatment:

Other: Chlorhexidine Gluconate