Tolerance of Chlorhexidine Gluconate Vaginal Cleansing Solution

Phase 4

Completed

• Conditions: Surgical Preparation of the Vagina
• Interventions: Drug: 4% Chlorhexidine Gluconate; Drug: Povidone-Iodine

• Registration Number: NCT03305159
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-09-04
• Study First Submitted QC: 2017-10-06
• Study First Posted: 2017-10-09
• Primary Completion: 2018-04-01
• Study Completion: 2018-04-15
• Results First Submitted: 2019-04-11
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-09
• Last Update Submitted: 2019-06-09
• Results First Posted: 2019-06-27
• Last Update Posted: 2019-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 134

Inclusion Criteria

1. Undergoing hysteroscopy
2. Gynecologic dilation & curettage
3. Endometrial ablation
4. Essure without concomitant laparoscopy

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention (4% Chlorhexidine gluconate)	4% Chlorhexidine Gluconate	Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.
Control (Povidone Iodine)	Povidone-Iodine	Patients to receive povidone iodine for the surgical preparation of the vagina.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Prentice Women's Hospital - Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States