Clinical trial NCT04048356: Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures
Official title: Chlorhexidine Gluconate Versus Povidone Iodine for Vaginal Surgical Preparation for Urogynecological Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pelvic Organ Prolapse
Urinary Incontinence
Pelvic Floor Disorders
Gynecologic Disease
Post-Op Infection
Surgical Site Infection
Urinary Tract Infections
Keywords: Urogynecology
Surgery
Antiseptic Preparation
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 137
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 infections.

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 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.

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

Primary outcomes:
measure: Rate of Urinary Tract Infection
timeFrame: 2 weeks post operatively
Secondary outcomes:
measure: Rate of Surgical Site Infection
timeFrame: 14 days postoperatively
measure: Vaginal Irritation
timeFrame: Post operative day 1
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Karen Taylor, BA
role: STUDY_DIRECTOR
References:
citation: Rockefeller NF, Petersen TR, Komesu YM, Meriwether K, Dunivan G, Ninivaggio C, Jeppson PC. Chlorhexidine gluconate vs povidone-iodine vaginal antisepsis for urogynecologic surgery: a randomized controlled noninferiority trial. Am J Obstet Gynecol. 2022 Jul;227(1):66.e1-66.e9. doi: 10.1016/j.ajog.2021.12.260. Epub 2021 Dec 29.