Tolerance of Chlorhexidine Gluconate Vaginal Cleansing Solution

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03305159
• Collaborator: (none)
• Enrollment: 134
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.4
• Patients Per Site Per Month: 15.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Preparation of the Vagina	Drug: Povidone-Iodine; Drug: 4% Chlorhexidine Gluconate	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 134 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Eligible patients will be randomized to either the control (povidone iodine) or intervention (chlorhexidine gluconate).Eligible patients will be randomized to either the control (povidone iodine) or intervention (chlorhexidine gluconate).
• Masking: Single (Participant)
• Masking Description: Patients will be randomized to the control or intervention and not be told which antiseptic they received for the surgical preparation of the vagina.
• Primary Purpose: Other
• Official Title: Tolerance of Chlorhexidine Gluconate Versus Povidone Iodine Vaginal Cleansing Solution: a Randomized Control Trial
• Actual Study Start Date: Aug 1, 2017
• Actual Primary Completion Date: Apr 1, 2018
• Actual Study Completion Date: Apr 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control (Povidone Iodine) Patients to receive povidone iodine for the surgical preparation of the vagina.	Drug: Povidone-Iodine; Patients will receive povidone iodine for the surgical preparation of the vagina.
Experimental: Intervention (4% Chlorhexidine gluconate) Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.	Drug: 4% Chlorhexidine Gluconate; Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prentice Women's Hospital - Northwestern Memorial Hospital	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Magdy Milad, MD, Northwestern University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 9, 2018

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Magdy Milad, MD, Principal Investigator, Northwestern University
• ClinicalTrials.gov Identifier: NCT03305159
• Other Study ID Numbers: STU00204759
• First Posted: Oct 9, 2017
• Last Update Posted: Jun 27, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Povidone-Iodine; Povidone

Study Results

Participant Flow

Arm/Group Title	Control (Povidone Iodine)	Intervention (4% Chlorhexidine Gluconate)
Arm/Group Description	Patients to receive povidone iodine for the surgical preparation of the vagina. Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina.	Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina. 4% Chlorhexidine Gluconate: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.
Period Title: Overall Study
STARTED	66	68
COMPLETED	63	60
NOT COMPLETED	3	8

Baseline Characteristics

Arm/Group Title	Control (Povidone Iodine)	Intervention (4% Chlorhexidine Gluconate)	Total
Arm/Group Description	Patients to receive povidone iodine for the surgical preparation of the vagina. Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina.	Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina. 4% Chlorhexidine Gluconate: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.	Total of all reporting groups
Overall Participants	63	60	123
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	59 93.7%	59 98.3%	118 95.9%
>=65 years	4 6.3%	1 1.7%	5 4.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46 (10)	44 (9)	45 (9.7)
Sex: Female, Male (Count of Participants)
Female	63 100%	60 100%	123 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	4 6.3%	2 3.3%	6 4.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	8 12.7%	9 15%	17 13.8%
White	41 65.1%	39 65%	80 65%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	10 15.9%	10 16.7%	20 16.3%
Region of Enrollment (participants) [Number]
United States	63 100%	60 100%	123 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Number of participants in control and active groups

Arm/Group Title	Control (Povidone Iodine)	Intervention (4% Chlorhexidine Gluconate)
Arm/Group Description	Patients to receive povidone iodine for the surgical preparation of the vagina. Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina.	Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina. 4% Chlorhexidine Gluconate: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.
Measure Participants	63	59
Vaginal dryness	4 6.3%	11 18.3%
Vaginal burning	8 12.7%	25 41.7%
Unusual vaginal discharge	10 15.9%	14 23.3%
Pain of burning with urination	9 14.3%	17 28.3%
Vaginal itchiness	7 11.1%	7 11.7%

Adverse Events

Time Frame	Data were collected for each patient immediately postoperatively to 24-48 hours postoperatively.
Adverse Event Reporting Description	The survey of vaginal & urinary symptoms used in this study was designed using the PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) created by the NIH & NCI 7. The language & format of the PTO-CTCAE questions have been cognitively tested. Questions on vaginal burning and itching were investigator-developed items using similar language as the PRO-CTCAE, since these adverse events were not contained in the PRO-CTCAE item library.
Arm/Group Title	Control (Povidone Iodine)		Intervention (4% Chlorhexidine Gluconate)
Arm/Group Description	Patients to receive povidone iodine for the surgical preparation of the vagina. Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina.		Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina. 4% Chlorhexidine Gluconate: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.
All Cause Mortality
	Control (Povidone Iodine)		Intervention (4% Chlorhexidine Gluconate)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		0/60 (0%)
Serious Adverse Events
	Control (Povidone Iodine)		Intervention (4% Chlorhexidine Gluconate)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Control (Povidone Iodine)		Intervention (4% Chlorhexidine Gluconate)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		1/59 (1.7%)
Skin and subcutaneous tissue disorders
Severe Swelling	0/63 (0%)	0	1/59 (1.7%)	1

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.