Tolerance of Chlorhexidine Gluconate Vaginal Cleansing Solution

Northwestern University

Status and phase: Completed; Phase 4

Conditions: Surgical Preparation of the Vagina

Treatments: Drug: Povidone-Iodine; Drug: 4% Chlorhexidine Gluconate

Study type: Interventional

Funder types: Other

Identifiers

NCT03305159

STU00204759

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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134 participants in 2 patient groups

Control (Povidone Iodine)

Active Comparator group

Description:

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

Treatment:

Drug: Povidone-Iodine

Intervention (4% Chlorhexidine gluconate)

Experimental group

Description:

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

Treatment:

Drug: 4% Chlorhexidine Gluconate