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

September 11, 2012 updated by: Curtis Baysinger, Vanderbilt University
The purpose of this study will be to assess whether forced air warming decreases the rate of surgical site infections following cesarean section.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Bair Hugger device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
treatment effects on wound infection
Time Frame: As is current standard of care post procedure
As is current standard of care post procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
treatment effects on endometritis
Time Frame: as is current standard of care post procedure
as is current standard of care post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: Curtis L Baysinger, M.D., Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

June 2, 2008

First Submitted That Met QC Criteria

June 9, 2008

First Posted (Estimate)

June 12, 2008

Study Record Updates

Last Update Posted (Estimate)

September 13, 2012

Last Update Submitted That Met QC Criteria

September 11, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 70346

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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