Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures

Phase 3

Completed

• Conditions: Post-Op Infection; Pelvic Organ Prolapse; Gynecologic Disease; Surgical Site Infection; Urinary Tract Infections; Urinary Incontinence; Pelvic Floor Disorders
• Interventions: Drug: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.

• Registration Number: NCT04048356
• Lead Sponsor: University of New Mexico

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.

Study Timeline

• Study Start: 2019-07-15
• Study First Submitted: 2019-08-02
• Study First Submitted QC: 2019-08-05
• Study First Posted: 2019-08-07
• Primary Completion: 2021-02-28
• Study Completion: 2021-03-14
• Status Verified: 2023-06
• Results First Submitted: 2023-06-20
• Results First Submitted QC: 2023-06-20
• Last Update Submitted: 2023-06-20
• Results First Posted: 2023-07-10
• Last Update Posted: 2023-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 137

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine gluconate	Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.	Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Povidone Iodine	Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.	Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.

Primary Outcome Measures

Name	Time	Method
Rate of Urinary Tract Infection	2 weeks post operatively	Urinary tract infection as defined by positive urine culture of \>10,000 cfu, or empirically treated symptoms.

Secondary Outcome Measures

Name	Time	Method
Vaginal Irritation	Post operative day 1	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))
Rate of Surgical Site Infection	14 days postoperatively	Surgical site infection as defined by CDC guidelines: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf

Trial Locations

Locations (1)

University of New Mexico Health Sciences Center; 🇺🇸 Albuquerque, New Mexico, United States