The Effect of Forced Air Warming During Cesarean Section on Postoperative Infectious Morbidity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Vanderbilt University
- Locations
- 1
- Primary Endpoint
- treatment effects on wound infection
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
A
Patients in Group A will undergo passive warming with a warmed cotton blanket placed over their upper extremities
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.
Intervention: forced-air warming (Device)
Outcomes
Primary Outcomes
treatment effects on wound infection
Time Frame: As is current standard of care post procedure
Secondary Outcomes
- treatment effects on endometritis(as is current standard of care post procedure)
Investigators
Curtis Baysinger
Associate Professor
Vanderbilt University