Supplemental Oxygen and the Risk of Surgical Site Infection

Santa Clara Valley Health & Hospital System1,202 enrolled

Overview

This is a study to see whether increasing the oxygen concentration during and after a cesarean section decreases the infection rate.

This is a double-blinded prospective randomized,controlled trial to evaluate whether using a higher concentration of oxygen during and after surgery helps to decrease the wound infection rate in patients undergoing cesarean sections.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

1,202

Conditions

Surgical Site Infection

Interventions

Oxygen by maskOTHER

Postoperatively, an aerosol face mask is used to deliver oxygen at 80%

Oxygen by maskOTHER

Postoperatively, an aerosol face mask is used to deliver oxygen at 30%

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * mentally competent patients undergoing cesarean section under spinal or epidural anesthesia Exclusion Criteria: * fever/chorioamnionitis; GBS positive on antibiotics; immunocompromised / HIV patients; on antibiotics for any reason; general anesthesia; age less than 18 years custody patients stat cesarean section

Locations (1)

Santa clara Valley Medical Center

San Jose, California, United States

Outcomes

Primary Outcomes

Surgical site infection

Time frame: 2 weeks

Data from ClinicalTrials.gov

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