Chlorhexidine vs Povidone Iodine Vaginal Prep in Decreasing Postoperative Infection in Total Laparoscopic Hysterectomy

Randomized Control Trial: Chlorhexidine vs Povidone Iodine Vaginal Prep in Decreasing Postoperative Infection in Total Laparoscopic Hysterectomy

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.

Study Overview

• Status: Withdrawn
• Conditions: Preventative Laparoscopic Hysterectomy
• Intervention / Treatment: Diagnostic test: 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.

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: povidone betadine	Diagnostic test: 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.; 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.
Active Comparator: chlorhexidine	Diagnostic test: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	before antibiotic administration, 30 minutes after vaginal prep and q1hr thereafter until the surgery was completed

Collaborators and Investigators

• Sponsor: Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: January 23, 2022
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: 4% chlorhexidine; 10% povidone iodine
• Additional Relevant MeSH Terms: Infections; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 15037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No