Chlorhexidine vs Povidone Iodine Vaginal Prep in Decreasing Postoperative Infection in Total Laparoscopic Hysterectomy
Primary Purpose
Preventative Laparoscopic Hysterectomy
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
A vaginal swab for aerobic and anaerobic cultures before antibiotic administration, 30 minutes after vaginal prep and every hour thereafter until the surgery is completed.
Sponsored by
About this trial
This is an interventional prevention trial for Preventative Laparoscopic Hysterectomy focused on measuring 4% chlorhexidine, 10% povidone iodine
Eligibility Criteria
Inclusion Criteria: Patients who are scheduled for total laparoscopic hysterectomy Exclusion Criteria: not able to consent in English or have allergy to the 10% povidone betadine or 4% chlorhexidine solution.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
povidone betadine
chlorhexidine
Arm Description
Outcomes
Primary Outcome Measures
The number of positive cultures in each arm will be compared.
The number of positive cultures in each arm will be assessed using vaginal swabs to look for contaminated specimens. Positive cultures will be defined as colony forming counts of >5000cfu, and these will be compared in each arm to determine which preparation is more effective
Secondary Outcome Measures
Full Information
NCT ID
NCT05692986
First Posted
January 23, 2022
Last Updated
January 11, 2023
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT05692986
Brief Title
Chlorhexidine vs Povidone Iodine Vaginal Prep in Decreasing Postoperative Infection in Total Laparoscopic Hysterectomy
Official Title
Randomized Control Trial: Chlorhexidine vs Povidone Iodine Vaginal Prep in Decreasing Postoperative Infection in Total Laparoscopic Hysterectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Did not move forward due to staffing
Study Start Date
February 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
January 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized control trial which will randomize patients who will be undergoing laparoscopic (conventional or robotic assisted) total hysterectomy to vaginal prep with 4% chlorhexidine gluconate vs 10% povidone iodine. There is paucity of information regarding the superiority of one over the other.
Detailed Description
This is a randomized control trial. During surgery, preoperative vaginal prep is routinely done for hysterectomies. This can be completed with 10% povidone iodine or with 4% chlorhexidine preparation. This study will investigate whether the routine use of betadine vaginal prep in comparison to chlorhexidine prep is superior. Patients will be informed of the study at the time of their preoperative visit in the gynecology clinic at time of surgical scheduling. The attached informed consent sheet will be given to the patient for their signature. The patients will be randomized to receive either 10% povidone iodine or with 4% chlorhexidine vaginal preparation solution. This is not anticipated to take extra time or resources in the operating room setting because the surgical vaginal preparation solutions are typically readily available in the operating room setting. The patients will be assigned an envelope when they are in clinic after they have signed the consent form and that will be the group they are randomized to.
Once the patients are randomized, it is anticipated that 50 patients will be enrolled in each study arm. Following randomization patients will receive the vaginal preparation per the randomization assignment. The patient will be blinded to the study arm. The provider will not be blinded. Follow-up will occur on postoperative day #1 by phone call, and at the 2-week and 6-week follow-up visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preventative Laparoscopic Hysterectomy
Keywords
4% chlorhexidine, 10% povidone iodine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
povidone betadine
Arm Type
Active Comparator
Arm Title
chlorhexidine
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
A vaginal swab for aerobic and anaerobic cultures before antibiotic administration, 30 minutes after vaginal prep and every hour thereafter until the surgery is completed.
Intervention Description
This is a randomized control trial that will compare chlorhexidine vaginal prep with iodine vaginal prep. Our primary outcome will be assessed using a vaginal swab test to look for aerobic and anaerobic cultures. Positive cultures will be defined as colony forming count of >5000cfu. All patients will receive preoperative antibiotics. Patients will receive a vaginal swab for aerobic and anaerobic cultures before antibiotic administration, 30 minutes after vaginal prep and every hour thereafter until the surgery was completed.
Primary Outcome Measure Information:
Title
The number of positive cultures in each arm will be compared.
Description
The number of positive cultures in each arm will be assessed using vaginal swabs to look for contaminated specimens. Positive cultures will be defined as colony forming counts of >5000cfu, and these will be compared in each arm to determine which preparation is more effective
Time Frame
before antibiotic administration, 30 minutes after vaginal prep and q1hr thereafter until the surgery was completed
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients who are scheduled for total laparoscopic hysterectomy
Exclusion Criteria:
not able to consent in English or have allergy to the 10% povidone betadine or 4% chlorhexidine solution.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Chlorhexidine vs Povidone Iodine Vaginal Prep in Decreasing Postoperative Infection in Total Laparoscopic Hysterectomy
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