Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures

Study Overview
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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.

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.

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

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

Intervention / Treatment
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* Drug: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine gluconate<br>Chlorhexidine gluconate 2% 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.<br>* Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.<br>|
| Active Comparator: Povidone Iodine<br>Povidone iodine 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.<br>* Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Urinary Tract Infection | Urinary tract infection as defined by positive urine culture of >10,000 cfu, or empirically treated symptoms. | 2 weeks post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Surgical Site Infection | Surgical site infection as defined by CDC guidelines: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf | 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)) | Post operative day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urogynecology, Surgery, Antiseptic Preparation