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

Vanderbilt University

Status: Withdrawn

Conditions: Cesarean Section

Treatments: Device: forced-air warming

Study type: Interventional

Funder types: Other

Identifiers

NCT00696462

70346

Details and patient eligibility

About

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

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

A

No Intervention group

Description:

Patients in Group A will undergo passive warming with a warmed cotton blanket placed over their upper extremities

B

Active Comparator group

Description:

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.

Treatment:

Device: forced-air warming