Phase 3
N=137
Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures
Pelvic Organ Prolapse · Urinary Incontinence · Pelvic Floor Disorders · Gynecologic Disease · Post-Op Infection
Bottom Line
View on ClinicalTrials.gov: NCT04048356 ↗Enrolled (actual)
137
Serious AEs
6.7%
Results posted
Jul 2023
Primary outcome: Primary: Rate of Urinary Tract Infection — 4; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of New Mexico
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Urinary Tract Infection |
4; 7 | — |
| SECONDARY Rate of Surgical Site Infection |
1; 2 | — |
| SECONDARY Vaginal Irritation |
50; 50; 1; 0; 1; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04048356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.