A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections

November 8, 2012 updated by: Memorial University of Newfoundland

Povidone-iodine vs. Chlorhexidine Gluconate - A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections

The purpose of this study is to find out if chlorhexidine gluconate solution is better at reducing the rate of wound infection after cesarean section compared to povidone-iodine.

Study Overview

Status

Terminated

Conditions

Detailed Description

Wound infection is a universal potential morbidity to any type of surgery. Over the years many studies have been completed to evaluate ways to decrease this morbidity. Recent literature has looked at different types of surgical solutions used in pre-operative cleansing. Chlorhexidine and povidone-iodine are two standard surgical prep solutions used on a global scale. The most recent literature has shown that chlorhexidine has a decreased wound infection rate for longer surgeries. Cesarean section, as a surgical time, varies from 20 - 60 minutes. There has been no known literature regarding wound infection rates using these two solutions in elective cesarean sections. This trial will review the rates of wound infection using chlorhexidine and povidone-iodine during elective cesarean section and determine if there is any statistically significant difference between the two solutions. The results could potentially decrease wound infection rates, decrease morbidity, decrease hospital length of stay, and help to guide further surgical management.

Study Type

Interventional

Enrollment (Actual)

268

Phase

  • Phase 3

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

    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1E 5K9
        • Women' s Health Centre, Eastern Health

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age >19 years
  • Gestational age > 37 weeks
  • Booked elective cesarean section

Exclusion Criteria:

  • Gestational age < 37 weeks
  • Premature rupture of membranes
  • Onset of labor prior to procedure
  • Evidence of maternal sepsis; maternal fever > 38.5C
  • LSCS for emergency issues: non-reassuring fetal status, placental abruption, failed induction

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
povidone-iodine
Abdominal surgical field cleaned with 5% povidone-iodine detergent scrub, detergent cleaned from surgical area with sterile water, and then painted with 1% povidone-iodine solution.
Other Names:
  • Betadine, Povidone, Minidyne
Active Comparator: B
chlorhexidine gluconate
Abdominal surgical field painted once using 2% chlorhexidine in 70% alcohol.
Other Names:
  • Dexidine, Avagard, Bactoshield

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
to determine the rate of wound infection using two standard wound preparations: povidone-iodine and chlorhexidine gluconate
Time Frame: within 6 weeks following surgery
within 6 weeks following surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
readmission to hospital
Time Frame: within 6 weeks following surgery
within 6 weeks following surgery
extended length of admission
Time Frame: within 6 weeks following surgery
within 6 weeks following surgery
need for intravenous antibiotics
Time Frame: within 6 weeks following surgery
within 6 weeks following surgery
need for repeat procedure such as drainage
Time Frame: within 6 weeks following surgery
within 6 weeks following surgery
increased outpatient surveillance
Time Frame: within 6 weeks following surgery
within 6 weeks following surgery

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Paula Mallaley, MD, Resident, Obstetrics and Gynecology, Memorial University of Newfoundland

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

December 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

September 10, 2007

First Submitted That Met QC Criteria

September 10, 2007

First Posted (Estimate)

September 11, 2007

Study Record Updates

Last Update Posted (Estimate)

November 9, 2012

Last Update Submitted That Met QC Criteria

November 8, 2012

Last Verified

November 1, 2012

More Information

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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