Comparison of Surgical Skin Preps During Cesarean Deliveries

September 2, 2017 updated by: David Garry, Montefiore Medical Center
In women that undergo non-emergency cesarean delivery, we are comparing the skin preparation solutions for best outcome of surgical site infection. The three different solutions are: Group 1: Iodine povidone based skin preparation solution. Group 2: Chlorhexidine based skin preparation solution or Group 3: Combination usage of iodine povidone and chlorhexidine based skin preparation solutions. Women are prospectively randomized to one of the three groups and followed until thier postpartum visit at 6-8 weeks following delivery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Currently the skin preparation solutions currently in use for cesarean delivery are chlorhexidine-alcohol based solutions or iodine povidone solutions There had been no recommendations of which surgical skin prep wound be best utilized for cesarean delivery, especially if the patient has risk factors for surgical site infection. Chlorhexidine solution has been reported to take minimal of 2 minutes after application to decrease the bacterial load, and continue to decrease the bacteria load up to 1 hour. Iodine povidone solution has been reported to be completely effective within 4 minutes of application. Patient's risk factor for surgical site infection, including obesity, history of incision complications, maternal diabetes, chorioamnionitis, potentially influence which surgical skin prep to be applied. Finally, the majority of postpartum infections manifest after hospital discharge and most of these post-discharge infections are diagnosed and treated entirely in the ambulatory setting, without the patients' returning to the hospital.

The purpose of the study is:

  1. To compare chlorhexidine based solution, iodine povidone solution, and combination of both agents in cesarean delivery skin preparation solution for prevention of surgical site infection (SSI)
  2. To determine if surgical site infection (SSI) risk factors should guide selection of one specific surgical skin preparation solution.

This will be a prospective randomized observational study of the women presenting for care to the Montefiore Medical Center. All patients will undergo routine obstetrical care and preparation for cesarean delivery as if they were not participating in this research study. All patients in the study will receive the pre-operative intravenous antibiotics pre-operatively as part of departmental protocol for cesarean delivery.

The patients will be randomized after informed consent obtained into one of three groups: Group 1: Iodine povidone based skin preparation solution. Group 2: Chlorhexidine based skin preparation solution or Group 3: Combination usage of iodine povidone and chlorhexidine based skin preparation solutions. Sequentially numbered envelopes will contain the group of randomization for the patient created by a computer generated program which will occur prior to commencement of the study.

Surgical preparation will follow the departmental protocol as if the patient were not in the study with exception of the skin preparation. Once the patient is randomized to the skin preparation group, the corresponding skin preparation solution will be used in accordance to manufacturer's guidelines for the product and Departmental protocol. If randomized to group 3 (combination), the iodine based preparation will occur first followed by the chlorhexidine based skin preparation. All groups will wait a minimal of 4 minutes prior to skin incision after application of skin prep, and all patients will be surgically draped with the standard drapes as if not participating in a study. Cesarean delivery will occur following the technique of the surgeon, including skin closure method, suture or staples.

All patients will be followed until the routine postpartum visit occurs at 6-8 weeks following delivery. Postpartum visit information will be extracted from the medical record. If no postpartum visit occurs, the patient will be contacted by telephone at 8 weeks post delivery and asked about any incisional complications which may have occurred and required treatment by as physician or healthcare provider in the office or hospital.

Study Type

Interventional

Enrollment (Actual)

1404

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center Weiler Division
      • The Bronx, New York, United States, 10466
        • Montefiore Medical Center Wakefield Division

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Gestational age > 37 weeks 0/7 days
  • Non-emergency indication for cesarean

Exclusion Criteria:

  • Urogenital tract infection within 2 weeks prior to surgery
  • Chronic oral or injectable steroid use (> 2 weeks)
  • Emergency cesarean delivery
  • Participation in another research study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Combination iodine and chlorhexidine
The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery.
Drug: Combination iodine and chlorhexidine
Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery
Active Comparator: Chlorhexidine
Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery
Drug: Chlorhexidine
Chlorhexidine skin preparation solution prior to cesarean delivery
Active Comparator: Iodine povidone
Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery
Drug: Iodine povidone
Iodine skin preparation solution prior to cesarean delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cesarean Surgical Site Infection
Time Frame: 42 days after delivery
Surgical site infection will follow CDC guidelines: A) Superficial incisional surgical site infection B) Deep incisional surgical site infection or C) Organ/space surgical site infection.
42 days after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Study Chair: David A Wallach, CIP, Einstein IRB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

June 3, 2013

First Submitted That Met QC Criteria

June 3, 2013

First Posted (Estimate)

June 6, 2013

Study Record Updates

Last Update Posted (Actual)

October 2, 2017

Last Update Submitted That Met QC Criteria

September 2, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCI#12-07-248

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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