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

Not Applicable

Withdrawn

• Conditions: Preventative Laparoscopic Hysterectomy
• Interventions: 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.

• Registration Number: NCT05692986
• Lead Sponsor: Henry Ford Health System

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.

Study Timeline

• Study First Submitted: 2022-01-23
• Study Start: 2022-02-01
• Status Verified: 2023-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Study First Submitted QC: 2023-01-11
• Last Update Submitted: 2023-01-11
• Study First Posted: 2023-01-20
• Last Update Posted: 2023-01-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
povidone betadine	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.	-
chlorhexidine	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.	-

Primary Outcome Measures

Name	Time	Method
The number of positive cultures in each arm will be compared.	before antibiotic administration, 30 minutes after vaginal prep and q1hr thereafter until the surgery was completed	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