- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00528008
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
Intervention / Treatment
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:
|
Active Comparator: B
chlorhexidine gluconate
|
Abdominal surgical field painted once using 2% chlorhexidine in 70% alcohol.
Other Names:
|
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIC07.33
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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Clinical Trials on povidone-iodine solution
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-
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-
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