Back to resultsThe Effect of Forced Air Warming During Cesarean Section on Postoperative Infectious Morbidity
Primary Purpose
Cesarean Section
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
forced-air warming
Sponsored by
About this trial
This is an interventional prevention trial for Cesarean Section focused on measuring forced-air warming, Bair Hugger, cesarean section, postoperative infection, surgical site infections
Eligibility Criteria
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.
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
A
B
Arm Description
Patients in Group A will undergo passive warming with a warmed cotton blanket placed over their upper extremities
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.
Outcomes
Primary Outcome Measures
treatment effects on wound infection
Secondary Outcome Measures
treatment effects on endometritis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00696462
Brief Title
The Effect of Forced Air Warming During Cesarean Section on Postoperative Infectious Morbidity
Official Title
The Effect of Forced Air Warming During Cesarean Section on Postoperative Infectious Morbidity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Study terminated for lack of funds to initiate study
Study Start Date
March 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study will be to assess whether forced air warming decreases the rate of surgical site infections following cesarean section.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section
Keywords
forced-air warming, Bair Hugger, cesarean section, postoperative infection, surgical site infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
No Intervention
Arm Description
Patients in Group A will undergo passive warming with a warmed cotton blanket placed over their upper extremities
Arm Title
B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
forced-air warming
Other Intervention Name(s)
Bair Hugger device
Intervention Description
forced-air warming device
Primary Outcome Measure Information:
Title
treatment effects on wound infection
Time Frame
As is current standard of care post procedure
Secondary Outcome Measure Information:
Title
treatment effects on endometritis
Time Frame
as is current standard of care post procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Curtis L Baysinger, M.D.
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.vandydreamteam.com
Description
Vanderbilt University Medical Center Department of Anesthesiology
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The Effect of Forced Air Warming During Cesarean Section on Postoperative Infectious Morbidity
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