The Effect of Forced Air Warming During Cesarean Section on Postoperative Infectious Morbidity - Full Text View

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00696462

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

MedlinePlus related topics: Cesarean Section

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	The Effect of Forced Air Warming During Cesarean Section on Postoperative Infectious Morbidity

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 ]

Estimated Enrollment:	870
Study Start Date:	March 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: No Intervention Patients in Group A will undergo passive warming with a warmed cotton blanket placed over their upper extremities
B: Active Comparator 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

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

Vanderbilt University Medical Center Department of Anesthesiology This link exits the ClinicalTrials.gov site

Responsible Party:	Vanderbilt University Medical Center ( Curtis Baysinger )
Study ID Numbers:	70346
Study First Received:	June 2, 2008
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00696462
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 January 15, 2009