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Completed

NCT Number: NCT03305159

Tolerance of Chlorhexidine Gluconate Vaginal Cleansing Solution

Conduct a randomized control study to compare the tolerance of 4% chlorhexidine gluconate/4% isopropyl alcohol versus povidone iodine vaginal cleansing solutions for surgical preparations of the vagina. Patients will be randomized to either control (povidone iodine) or experimental (chlorhexidine gluconate), and then be given a short survey prior to and immediately after surgery, and again 24-48 hours via phone asking them about the presence and severity of vaginal dryness, burning, itchiness, unusual vaginal discharge, and pain or burning with urination.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Prentice Women's Hospital - Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

About this study

Surgical site antisepsis is critical in preventing surgical site infections. Although chlorhexidine gluconate has proven to be superior to povidone iodine for surgical site antisepsis, povidone iodine is the only FDA-approved antiseptic solution for surgical preparation of the vagina. Many surgeons are hesitant to use chlorhexidine gluconate for preoperative vaginal cleansing due to the alcohol dissolvent present in the solutions that is implicated in a greater risk of irritation. Yet, there has been no randomized study to illustrate whether the risk of vaginal irritation is greater in chlorhexidine gluconate versus povidone iodine. Thus, the purpose of the study is to conduct a randomized control trial to compare the tolerance of 4% chlorhexidine gluconate to povidone iodine using patient-reported outcomes of vaginal or urinary symptoms. Patients will be randomized to either control or experimental, and then be given a short survey prior to and immediately after surgery, and again 24-48 hours via phone asking them about the presence and severity of vaginal dryness, burning, itchiness, unusual vaginal discharge, and pain or burning with urination.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Undergoing hysteroscopy
  • Gynecologic dilation & curettage
  • Endometrial ablation
  • Essure without concomitant laparoscopy

Exclusion criteria

  • Pregnant
  • Have a history of atopic dermatitis, vaginal irritation, allergic reactions, or anaphylaxis to chlorhexidine gluconate or povidone iodine.

Treatment and study plan

Povidone-Iodine

Drug

Patients will receive povidone iodine for the surgical preparation of the vagina.

4% Chlorhexidine Gluconate

Drug

Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.

Primary outcomes

  1. Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE)

    Time frame: Day of surgery to 24-48 hours after surgery

    To determine and compare the number of participants with vaginal or urinary symptoms after treatment with chlorhexidine gluconate versus povidone iodine vaginal cleansing solutions.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Tolerance of Chlorhexidine Gluconate Versus Povidone Iodine Vaginal Cleansing Solution: a Randomized Control Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 9, 2017
Registry last updated
Jun 27, 2019

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.