Back to resultsChlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures (CLNUP)
Primary Purpose
Pelvic Organ Prolapse, Urinary Incontinence, Pelvic Floor Disorders
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Urogynecology, Surgery, Antiseptic Preparation
Eligibility Criteria
Inclusion Criteria:
- Female Subjects >18 years of age
- English or Spanish speaking/reading
- Must be able to provide informed consent
- Undergoing urogynecologic procedures or surgery
Exclusion Criteria:
- Pregnant - all patients are verified regarding pregnancy status prior to gynecologic surgical intervention at all sites of surgery - for patients who are premenopausal and have a uterus, a urine pregnancy test is administered in the preoperative setting. Pregnancy status is also determined prior to this in the office setting by interview and patient provided history prior to offering surgery to the patient.
- Inability to return for follow-up visits
- No concurrent need for vaginal antisepsis, such as cases of sacral neuromodulation
- Lack of telephone
- Known allergy to either antiseptic agent
- Prisoners will not be eligible to participate in this study
Sites / Locations
- University of New Mexico Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Chlorhexidine gluconate
Povidone Iodine
Arm Description
Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Outcomes
Primary Outcome Measures
Rate of Urinary Tract Infection
Urinary tract infection as defined by positive urine culture of >10,000 cfu, or empirically treated symptoms.
Secondary Outcome Measures
Rate of Surgical Site Infection
Surgical site infection as defined by CDC guidelines: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf
Vaginal Irritation
Vaginal irritation (including specific symptoms of discomfort, burning, or itching) based on a 5-point scale (Likert type, from 0 minimum/better to 5 maximum/worse, total score reported))
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04048356
Brief Title
Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures
Acronym
CLNUP
Official Title
Chlorhexidine Gluconate Versus Povidone Iodine for Vaginal Surgical Preparation for Urogynecological Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
March 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of New Mexico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Urinary Incontinence, Pelvic Floor Disorders, Gynecologic Disease, Post-Op Infection, Surgical Site Infection, Urinary Tract Infections
Keywords
Urogynecology, Surgery, Antiseptic Preparation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants will be anesthetized during the intervention and will not be informed of the arm of their randomization
Allocation
Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chlorhexidine gluconate
Arm Type
Experimental
Arm Description
Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Arm Title
Povidone Iodine
Arm Type
Active Comparator
Arm Description
Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Intervention Type
Drug
Intervention Name(s)
Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Intervention Description
Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Primary Outcome Measure Information:
Title
Rate of Urinary Tract Infection
Description
Urinary tract infection as defined by positive urine culture of >10,000 cfu, or empirically treated symptoms.
Time Frame
2 weeks post operatively
Secondary Outcome Measure Information:
Title
Rate of Surgical Site Infection
Description
Surgical site infection as defined by CDC guidelines: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf
Time Frame
14 days postoperatively
Title
Vaginal Irritation
Description
Vaginal irritation (including specific symptoms of discomfort, burning, or itching) based on a 5-point scale (Likert type, from 0 minimum/better to 5 maximum/worse, total score reported))
Time Frame
Post operative day 1
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female Subjects >18 years of age
English or Spanish speaking/reading
Must be able to provide informed consent
Undergoing urogynecologic procedures or surgery
Exclusion Criteria:
Pregnant - all patients are verified regarding pregnancy status prior to gynecologic surgical intervention at all sites of surgery - for patients who are premenopausal and have a uterus, a urine pregnancy test is administered in the preoperative setting. Pregnancy status is also determined prior to this in the office setting by interview and patient provided history prior to offering surgery to the patient.
Inability to return for follow-up visits
No concurrent need for vaginal antisepsis, such as cases of sacral neuromodulation
Lack of telephone
Known allergy to either antiseptic agent
Prisoners will not be eligible to participate in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Taylor, BA
Organizational Affiliation
University of New Mexico
Official's Role
Study Director
Facility Information:
Facility Name
University of New Mexico Health Sciences Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34973179
Citation
Rockefeller NF, Petersen TR, Komesu YM, Meriwether K, Dunivan G, Ninivaggio C, Jeppson PC. Chlorhexidine gluconate vs povidone-iodine vaginal antisepsis for urogynecologic surgery: a randomized controlled noninferiority trial. Am J Obstet Gynecol. 2022 Jul;227(1):66.e1-66.e9. doi: 10.1016/j.ajog.2021.12.260. Epub 2021 Dec 29.
Results Reference
derived
Learn more about this trial
Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures
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