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

Not Applicable
Withdrawn
Conditions
Cesarean Section
Interventions
Device: forced-air warming
Registration Number
NCT00696462
Lead Sponsor
Vanderbilt University
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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
Female
Target Recruitment
Not specified
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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Bforced-air warmingPatients in Group B will have a forced-air warming device applied to the upper body above the waist at the 43 degree Celsius setting.
Primary Outcome Measures
NameTimeMethod
treatment effects on wound infectionAs is current standard of care post procedure
Secondary Outcome Measures
NameTimeMethod
treatment effects on endometritisas is current standard of care post procedure

Trial Locations

Locations (1)

Vanderbilt University Medical Center

🇺🇸

Nashville, Tennessee, United States

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