CompletedPhase 3

Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures

United States137 participantsStarted 2019-07-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of Urinary Tract Infection

Timeframe: 2 weeks post operatively

Trial details

NCT IDNCT04048356

SponsorUniversity of New Mexico

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-02-28

Results submitted2023-06-20

View on ClinicalTrials.gov More Pelvic Organ Prolapse trials