Phase 4 N=134 Randomized Single-blind Other

Tolerance of Chlorhexidine Gluconate Vaginal Cleansing Solution

Surgical Preparation of the Vagina

Bottom Line

View on ClinicalTrials.gov: NCT03305159 ↗

Enrolled (actual)

134

Serious AEs

0.0%

Results posted

Jun 2019

Primary outcome: Primary: Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE) — 4; 11; 8; 25 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Povidone-Iodine (Drug); 4% Chlorhexidine Gluconate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Northwestern University
Primary completion: Apr 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE)	4; 11; 8; 25; 10; 14	—

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.

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT03305159). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.