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This study has been withdrawn prior to enrollment.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:
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
  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
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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 October 19, 2014