Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures (CLNUP)

Chlorhexidine Gluconate Versus Povidone Iodine for Vaginal Surgical Preparation for Urogynecological Procedures

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 137
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chlorhexidine gluconate; Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.	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.
Active Comparator: Povidone Iodine; Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of New Mexico
• Investigators: Study Director: Karen Taylor, BA, University of New Mexico

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): March 14, 2021

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 7, 2019

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Surgery; Urogynecology; Antiseptic Preparation
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Postoperative Complications; Disease Attributes; Urination Disorders; Pathological Conditions, Anatomical; Pregnancy Complications; Wound Infection; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases; Urinary Incontinence; Infections; Communicable Diseases; Prolapse; Pelvic Organ Prolapse; Urinary Tract Infections; Surgical Wound Infection; Pelvic Floor Disorders; Genital Diseases, Female
• Other Study ID Numbers: 19-039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No