Urinary Incontinence Clinical Trial
— CLNUPOfficial title:
Chlorhexidine Gluconate Versus Povidone Iodine for Vaginal Surgical Preparation for Urogynecological Procedures
NCT number | NCT04048356 |
Other study ID # | 19-039 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | July 15, 2019 |
Est. completion date | March 14, 2021 |
Verified date | June 2023 |
Source | University of New Mexico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 137 |
Est. completion date | March 14, 2021 |
Est. primary completion date | February 28, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico Health Sciences Center | Albuquerque | New Mexico |
Lead Sponsor | Collaborator |
---|---|
University of New Mexico |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
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