The Effect of Forced Air Warming During Cesarean Section on Postoperative Infectious Morbidity
September 11, 2012 updated by: Curtis Baysinger, Vanderbilt University
The purpose of this study will be to assess whether forced air warming decreases the rate of surgical site infections following cesarean section.
Study Overview
Detailed Description
Given the physiologic and experimental evidence regarding temperature regulation; it remains convincing that forced air warming is protective against the development of SSI.
We will set out to prospectively study the effect of forced air warming on patients undergoing cesarean section.
Study Type
Interventional
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
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Tennessee
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Nashville, Tennessee, United States, 37212
- Vanderbilt University Medical Center
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Adult (≥ 18 years old) female subjects who will undergo cesarean delivery regardless of indication.
- Subjects who have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Patients scheduled to receive prophylactic antibiotic therapy.
Exclusion Criteria:
- Patients who are undergoing a true emergent cesarean section that does not allow placement of the warming devices.
- Patients undergoing general anesthesia.
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: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: A
Patients in Group A will undergo passive warming with a warmed cotton blanket placed over their upper extremities
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Active Comparator: B
Patients in Group B will have a forced-air warming device applied to the upper body above the waist at the 43 degree Celsius setting.
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forced-air warming device
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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treatment effects on wound infection
Time Frame: As is current standard of care post procedure
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As is current standard of care post procedure
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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treatment effects on endometritis
Time Frame: as is current standard of care post procedure
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as is current standard of care post procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Curtis L Baysinger, M.D., Vanderbilt University Medical Center
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.
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
March 1, 2007
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
June 2, 2008
First Submitted That Met QC Criteria
June 9, 2008
First Posted (Estimate)
June 12, 2008
Study Record Updates
Last Update Posted (Estimate)
September 13, 2012
Last Update Submitted That Met QC Criteria
September 11, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 70346
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.