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Tolerance of Chlorhexidine Gluconate Vaginal Cleansing Solution

NCT03305159 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2019-06-27

Study results available
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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.

Conditions

  • Surgical Preparation of the Vagina

Interventions

DRUG

Povidone-Iodine

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

DRUG

4% Chlorhexidine Gluconate

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

Sponsors & Collaborators

Principal Investigators

  • Magdy Milad, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2018-04-01
Completion
2018-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03305159 on ClinicalTrials.gov