Tolerance of Chlorhexidine Gluconate Vaginal Cleansing Solution

NCT03305159 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STU00204759
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Preparation of the Vagina

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control (Povidone Iodine)

ACTIVE COMPARATOR

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

Drug: Povidone-Iodine

Intervention (4% Chlorhexidine gluconate)

EXPERIMENTAL

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

Drug: 4% Chlorhexidine Gluconate

Interventions

Povidone-Iodine DRUG

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

Control (Povidone Iodine)

4% Chlorhexidine Gluconate DRUG

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

Intervention (4% Chlorhexidine gluconate)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Prentice Women's Hospital - Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Links

• ACOG Solutions for the Surgical Preparation of the Vagina

MeSH Terms

Interventions

Povidone-Iodine; chlorhexidine gluconate

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Limitations and Caveats

Single-blinded design. Present study included participants undergoing hysteroscopic procedures these procedures themselves may certainly influence postoperative irritative symptoms. Loss of follow-up both immediately and 24-48 hours postoperative.

Results Point of Contact

• Title: Supriya Rastogi
• Organization: Northwestern University Feinberg School of Medicine

supriya.rastogi@northwestern.edu

supriya.rastogi@northwestern.e

Study Officials

• Magdy Milad, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be randomized to the control or intervention and not be told which antiseptic they received for the surgical preparation of the vagina.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Eligible patients will be randomized to either the control (povidone iodine) or intervention (chlorhexidine gluconate).

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: October 9, 2017
• Study Start: August 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 15, 2018
• Last Updated: June 27, 2019
• Results First Posted: June 27, 2019

Record last verified: 2019-06

Locations

US (1)