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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This study has been withdrawn prior to enrollment.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)
Information provided by (Responsible Party):
Curtis Baysinger, Vanderbilt University Identifier:
First received: June 2, 2008
Last updated: September 11, 2012
Last verified: September 2012
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
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 ]

Secondary Outcome Measures:
  • treatment effects on endometritis [ Time Frame: as is current standard of care post procedure ]

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT00696462

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: Curtis L Baysinger, M.D. Vanderbilt University Medical Center
  More Information

Additional Information:
Responsible Party: Curtis Baysinger, Associate Professor, Vanderbilt University Identifier: NCT00696462     History of Changes
Other Study ID Numbers: 70346
Study First Received: June 2, 2008
Last Updated: September 11, 2012

Keywords provided by Vanderbilt University:
forced-air warming
Bair Hugger
cesarean section
postoperative infection
surgical site infections processed this record on April 28, 2017