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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date June 2023
Source University of New Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.

Locations

Country Name City State
United States University of New Mexico Health Sciences Center Albuquerque New Mexico

Sponsors (1)

Lead Sponsor Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

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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