NCT04658355

Chlorhexidine Gluconate Versus Povidone-iodine

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: Female
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

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

Conditions

• Vaginal Flora Imbalance

Interventions

Type	Name	Description
OTHER	Chlorhexidine Gluconate	4% Chlorhexidine Gluconate vaginal cleansing solution as a surgical preparation.
OTHER	Povidone-iodine	10% povidone-iodine vaginal cleansing solution as a surgical preparation.

Timeline

• Start date: 2020-12-15
• Primary completion: 2021-08-01
• Completion: 2022-05-01
• First posted: 2020-12-08
• Last updated: 2020-12-08