Tolerance of Chlorhexidine Gluconate Vaginal Cleansing Solution

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-04-15

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.

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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.

Conditions

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Surgical Preparation of the Vagina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Patients will be randomized to the control or intervention and not be told which antiseptic they received for the surgical preparation of the vagina.

Study Groups

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Control (Povidone Iodine)

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

Group Type ACTIVE_COMPARATOR

Povidone-Iodine

Intervention Type DRUG

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

Intervention (4% Chlorhexidine gluconate)

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

Group Type EXPERIMENTAL

4% Chlorhexidine Gluconate

Intervention Type DRUG

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

Interventions

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Povidone-Iodine

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

Intervention Type DRUG

4% Chlorhexidine Gluconate

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes