Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 146
Summary
- Conditions
- Gynecologic Disease
- Pelvic Floor Disorders
- Pelvic Organ Prolapse
- Post-Op Infection
- Surgical Site Infection
- Urinary Incontinence
- Urinary Tract Infections
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Masking Description: Participants will be anesthetized during the intervention and will not be informed of the arm of their randomizationPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
The purpose of this randomized controlled trial is to determine whether there is a difference in efficacy of two of the most common commercially available vaginal surgical preparations. The first objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respec...
The purpose of this randomized controlled trial is to determine whether there is a difference in efficacy of two of the most common commercially available vaginal surgical preparations. The first objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to post-operative infections including urinary tract infections (both culture proven and empirically treated) and surgical site infections (as defined by the Centers for Disease Control). The second objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to vulvar and vaginal irritation.
Tracking Information
- NCT #
- NCT04048356
- Collaborators
- Not Provided
- Investigators
- Study Director: Karen Taylor, BA University of New Mexico
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