Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures

University of New Mexico137 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

137

Conditions

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

Interventions

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

Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Female Subjects \>18 years of age * English or Spanish speaking/reading * Must be able to provide informed consent * Undergoing urogynecologic procedures or surgery Exclusion Criteria: * Pregnant - all patients are verified regarding pregnancy status prior to gynecologic surgical intervention at all sites of surgery - for patients who are premenopausal and have a uterus, a urine pregnancy test is administered in the preoperative setting. Pregnancy status is also determined prior to this in the office setting by interview and patient provided history prior to offering surgery to the patient. * Inability to return for follow-up visits * No concurrent need for vaginal antisepsis, such as cases of sacral neuromodulation * Lack of telephone * Known allergy to either antiseptic agent * Prisoners will not be eligible to participate in this study

Locations (1)

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

Outcomes

Primary Outcomes

Rate of Urinary Tract Infection

Urinary tract infection as defined by positive urine culture of \>10,000 cfu, or empirically treated symptoms.

Time frame: 2 weeks post operatively

Secondary Outcomes

Rate of Surgical Site Infection

Surgical site infection as defined by CDC guidelines: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf

Time frame: 14 days postoperatively

Vaginal Irritation

Vaginal irritation (including specific symptoms of discomfort, burning, or itching) based on a 5-point scale (Likert type, from 0 minimum/better to 5 maximum/worse, total score reported))

Time frame: Post operative day 1

Data from ClinicalTrials.gov

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