Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 6:55 AM
Study NCT ID:
NCT04048356
Status:
COMPLETED
Last Update Posted:
2023-07-10
First Post:
2019-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures
Sponsor:
University of New Mexico
Organization:
Study Overview
Official Title:
Chlorhexidine Gluconate Versus Povidone Iodine for Vaginal Surgical Preparation for Urogynecological Procedures
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLNUP
Brief Summary:
This is a randomized controlled trial to determine if there is a difference between chlorhexidine gluconate and povidone iodine vaginal preparations for urogynecological surgery post operative infections.
Detailed 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 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: