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The Effect of Forced Air Warming During Cesarean Section on Postoperative Infectious Morbidity

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ClinicalTrials.gov Identifier: NCT00696462
Recruitment Status : Withdrawn (Study terminated for lack of funds to initiate study)
First Posted : June 12, 2008
Last Update Posted : September 13, 2012
Sponsor:
Information provided by (Responsible Party):
Curtis Baysinger, Vanderbilt University

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.

Condition or disease Intervention/treatment Phase
Cesarean Section Device: forced-air warming Not Applicable

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Forced Air Warming During Cesarean Section on Postoperative Infectious Morbidity
Study Start Date : March 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. treatment effects on wound infection [ Time Frame: As is current standard of care post procedure ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Medical Center

Additional Information:
Responsible Party: Curtis Baysinger, Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00696462     History of Changes
Other Study ID Numbers: 70346
First Posted: June 12, 2008    Key Record Dates
Last Update Posted: September 13, 2012
Last Verified: September 2012

Keywords provided by Curtis Baysinger, Vanderbilt University:
forced-air warming
Bair Hugger
cesarean section
postoperative infection
surgical site infections