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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00696462
• Other study ID #: 70346
• Status: Withdrawn
• Phase: N/A
• First received: June 2, 2008
• Last updated: September 11, 2012
• Start date: March 2007
• Est. completion date: April 2009

Study information

• Verified date: September 2012
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Device:
• forced-air warming
forced-air warming device

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment effects on wound infection		As is current standard of care post procedure	No
Secondary	treatment effects on endometritis		as is current standard of care post procedure	No

External Links

•   Vanderbilt University Medical Center Department of Anesthesiology