Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures

Urinary Incontinence Clinical Trial

— CLNUP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04048356
• Other study ID #: 19-039
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Genital Diseases, Female
• Gynecologic Disease
• Infections
• Pelvic Floor Disorders
• Pelvic Organ Prolapse
• Post-Op Infection
• Prolapse
• Surgical Site Infection
• Surgical Wound Infection
• Urinary Incontinence
• Urinary Tract Infections

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