The Effect of Forced Air Warming During Cesarean Section on Postoperative Infectious Morbidity
This study has been withdrawn prior to enrollment.
(Study terminated for lack of funds to initiate study)
Sponsor:
Vanderbilt University
Information provided by (Responsible Party):
Curtis Baysinger, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00696462
First received: June 2, 2008
Last updated: September 11, 2012
Last verified: September 2012
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Purpose
The purpose of this study will be to assess whether forced air warming decreases the rate of surgical site infections following cesarean section.
| Condition | Intervention |
|---|---|
|
Cesarean Section |
Device: forced-air warming |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | The Effect of Forced Air Warming During Cesarean Section on Postoperative Infectious Morbidity |
Resource links provided by NLM:
Further study details as provided by Vanderbilt University:
Primary Outcome Measures:
- treatment effects on wound infection [ Time Frame: As is current standard of care post procedure ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- treatment effects on endometritis [ Time Frame: as is current standard of care post procedure ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | March 2007 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: A
Patients in Group A will undergo passive warming with a warmed cotton blanket placed over their upper extremities
|
|
|
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.
|
Device: forced-air warming
forced-air warming device
Other Name: Bair Hugger device
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696462
Locations
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37212 | |
Sponsors and Collaborators
Vanderbilt University
Investigators
| Principal Investigator: | Curtis L Baysinger, M.D. | Vanderbilt University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Curtis Baysinger, Associate Professor, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00696462 History of Changes |
| Other Study ID Numbers: | 70346 |
| Study First Received: | June 2, 2008 |
| Last Updated: | September 11, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vanderbilt University:
|
forced-air warming Bair Hugger cesarean section postoperative infection surgical site infections |
ClinicalTrials.gov processed this record on May 19, 2013