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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Withdrawn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
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preventative Laparoscopic Hysterectomy focused on measuring 4% chlorhexidine, 10% povidone iodine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    January 23, 2022
    Last Updated
    January 11, 2023
    Sponsor
    Henry Ford Health System
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    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    Withdrawn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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