Status:
COMPLETED
Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures
Lead Sponsor:
University of New Mexico
Conditions:
Pelvic Organ Prolapse
Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 infecti...
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 obje...
Eligibility Criteria
Inclusion
- Female Subjects \>18 years of age
- English or Spanish speaking/reading
- Must be able to provide informed consent
- Undergoing urogynecologic procedures or surgery
Exclusion
- 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
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2021
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT04048356
Start Date
July 15 2019
End Date
March 14 2021
Last Update
July 10 2023
Active Locations (1)
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1
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87106