NCT00696462

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 12, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

September 13, 2012

Status Verified

September 1, 2012

Enrollment Period

2.1 years

First QC Date

June 2, 2008

Last Update Submit

September 11, 2012

Conditions

Cesarean Section

Keywords

forced-air warmingBair Huggercesarean sectionpostoperative infectionsurgical site infections

Outcome Measures

Primary Outcomes (1)

  • treatment effects on wound infection

    As is current standard of care post procedure

Secondary Outcomes (1)

  • treatment effects on endometritis

    as is current standard of care post procedure

Study Arms (2)

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

Interventions

forced-air warmingDEVICE

forced-air warming device

Also known as: Bair Hugger device
B

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who are undergoing a true emergent cesarean section that does not allow placement of the warming devices.
  • Patients undergoing general anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Links

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Curtis L Baysinger, M.D.

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 2, 2008

First Posted

June 12, 2008

Study Start

March 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

September 13, 2012

Record last verified: 2012-09

Locations

US(1)