Tolerance of Chlorhexidine Gluconate Vaginal Cleansing Solution

Surgical Preparation of the Vagina Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305159
• Other study ID #: STU00204759
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2017
• Est. completion date: April 15, 2018

Study information

• Verified date: June 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: April 15, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Undergoing hysteroscopy

2. Gynecologic dilation & curettage

3. Endometrial ablation

4. Essure without concomitant laparoscopy

Exclusion Criteria:

1. Pregnant

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

Related Conditions & MeSH terms

• Surgical Preparation of the Vagina

Intervention

Drug:
• Povidone-Iodine
Patients will receive povidone iodine for the surgical preparation of the vagina.
• 4% Chlorhexidine Gluconate
Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.

Locations

Country	Name	City	State
United States	Prentice Women's Hospital - Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE)	To determine and compare the number of participants with vaginal or urinary symptoms after treatment with chlorhexidine gluconate versus povidone iodine vaginal cleansing solutions.	Day of surgery to 24-48 hours after surgery

External Links

•   ACOG Solutions for the Surgical Preparation of the Vagina
•   Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis