Tolerance of Chlorhexidine Gluconate Vaginal Cleansing Solution

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgical Preparation of the Vagina

Intervention / Treatment
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* Drug: Povidone-Iodine
* Drug: 4% Chlorhexidine Gluconate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing hysteroscopy Gynecologic dilation & curettage Endometrial ablation Essure without concomitant laparoscopy Exclusion Criteria: Pregnant Have a history of atopic dermatitis, vaginal irritation, allergic reactions, or anaphylaxis to chlorhexidine gluconate or povidone iodine.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible patients will be randomized to either the control (povidone iodine) or intervention (chlorhexidine gluconate).
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |