Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2021-03-14

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participants will be anesthetized during the intervention and will not be informed of the arm of their randomization

Study Groups

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Chlorhexidine gluconate

Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Povidone Iodine

Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes