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

Tracking Information

First Received Date ^ICMJE

September 10, 2007

Last Updated Date

August 26, 2008

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

to determine the rate of wound infection using two standard wound preparations: povidone-iodine and chlorhexidine gluconate [ Time Frame: within 6 weeks following surgery ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To determine the rate of wound infection using two standard wound preparations: 1: povidone-iodine and 2: chlorhexidine gluconate. [ Time Frame: within 6 weeks following surgery ]

Change History

Complete list of historical versions of study NCT00528008 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

readmission to hospital [ Time Frame: within 6 weeks following surgery ] [ Designated as safety issue: No ]
extended length of admission [ Time Frame: within 6 weeks following surgery ] [ Designated as safety issue: No ]
need for intravenous antibiotics [ Time Frame: within 6 weeks following surgery ] [ Designated as safety issue: No ]
need for repeat procedure such as drainage [ Time Frame: within 6 weeks following surgery ] [ Designated as safety issue: No ]
increased outpatient surveillance [ Time Frame: within 6 weeks following surgery ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

1.readmission to hospital 2.extended length of admission 3.need for intravenous antibiotics 4.need for repeat procedure such as drainage 5.increased outpatient surveillance [ Time Frame: within 6 weeks following surgery ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Wound Infection

Intervention ^ICMJE

Other: povidone-iodine solution
Other: chlorhexidine gluconate

Study Arms / Comparison Groups

Active Comparator: povidone-iodine
Active Comparator: chlorhexidine gluconate

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

494

Estimated Completion Date

November 2009

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

19 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Donna R Hutchens, BN, RN

709-777-7471

donna.hutchens@easternhealth.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00528008

Responsible Party

Dr. Jillian Carpenter, Memorial University of Newfoundland, Obstectrics/Gynecology Resident

Study ID Numbers ^ICMJE

HIC07.33

Study Sponsor ^ICMJE

Memorial University of Newfoundland

Collaborators ^ICMJE

Eastern Health

Investigators ^ICMJE

Principal Investigator:

Jillian Carpenter, MD

Resident, Obstetrics and Gynecology, Memorial University of Newfoundland

Information Provided By

Memorial University of Newfoundland

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP