Clinical trial NCT03305159: Tolerance of Chlorhexidine Gluconate Vaginal Cleansing Solution
Official title: Tolerance of Chlorhexidine Gluconate Versus Povidone Iodine Vaginal Cleansing Solution: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgical Preparation of the Vagina
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be randomized to either the control (povidone iodine) or intervention (chlorhexidine gluconate).
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE)
timeFrame: Day of surgery to 24-48 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Prentice Women's Hospital - Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Magdy Milad, MD
role: PRINCIPAL_INVESTIGATOR
References: