The Effect of Forced Air Warming During Cesarean Section... | NCT00696462

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

NCT00696462

Sponsor

Vanderbilt University

Status

Withdrawn

Last Update Posted

Sep 13, 2012Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Cesarean Section

Interventions

forced-air warming

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study terminated for lack of funds to initiate study

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Apr 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Jun 2, 2008

First Submission Date that Met QC Criteria

Jun 9, 2008

First Posted Date

Jun 12, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2012

Last Update Posted Date

Sep 13, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
forced-air warming	Device	forced-air warming device	B	Bair Hugger device

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Curtis L Baysinger, M.D.	Vanderbilt University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Medical Center		Nashville	Tennessee	37212	United States

Label	URL
Vanderbilt University Medical Center Department of Anesthesiology	View source

Condition Browse Module

MeSH Terms

ID	Term
D013530	Surgical Wound Infection

Ancestor Terms

ID	Term
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided