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

NCT ID: NCT00696462

Last Updated: 2012-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-04-30

Brief Summary

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The purpose of this study will be to assess whether forced air warming decreases the rate of surgical site infections following cesarean section.

Detailed Description

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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.

Conditions

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Cesarean Section

Keywords

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forced-air warming Bair Hugger cesarean section postoperative infection surgical site infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

Patients in Group A will undergo passive warming with a warmed cotton blanket placed over their upper extremities

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

forced-air warming

Intervention Type DEVICE

forced-air warming device

Interventions

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forced-air warming

forced-air warming device

Intervention Type DEVICE

Other Intervention Names

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Bair Hugger device

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Curtis Baysinger

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Curtis L Baysinger, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Related Links

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http://www.vandydreamteam.com

Vanderbilt University Medical Center Department of Anesthesiology

Other Identifiers

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70346

Identifier Type: -

Identifier Source: org_study_id