NCT04048356

Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures

Chlorhexidine Gluconate Versus Povidone Iodine for Vaginal Surgical Preparation for Urogynecological Procedures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a randomized controlled trial to determine if there is a difference between chlorhexidine gluconate and povidone iodine vaginal preparations for urogynecological surgery post operative infections.

Detailed description

The purpose of this randomized controlled trial is to determine whether there is a difference in efficacy of two of the most common commercially available vaginal surgical preparations. The first objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to post-operative infections including urinary tract infections (both culture proven and empirically treated) and surgical site infections (as defined by the Centers for Disease Control). The second objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to vulvar and vaginal irritation.

Conditions

• Pelvic Organ Prolapse
• Urinary Incontinence
• Pelvic Floor Disorders
• Gynecologic Disease
• Post-Op Infection
• Surgical Site Infection
• Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.	Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.

Timeline

• Start date: 2019-07-15
• Primary completion: 2021-02-28
• Completion: 2021-03-14
• First posted: 2019-08-07
• Last updated: 2023-07-10
• Results posted: 2023-07-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study