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Completed

NCT Number: NCT04048356

Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Rate of Urinary Tract Infection

    Time frame: 2 weeks post operatively

    Urinary tract infection as defined by positive urine culture of >10,000 cfu, or empirically treated symptoms.

Secondary outcomes

  1. Rate of Surgical Site Infection

    Time frame: 14 days postoperatively

    Surgical site infection as defined by CDC guidelines: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf

  2. Vaginal Irritation

    Time frame: 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))

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

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

Acronym: CLNUP

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 7, 2019
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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