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Supplemental Oxygen and the Risk of Surgical Site Infection

Phase 4
Completed
Conditions
Surgical Site Infection
Interventions
Other: Oxygen by mask
Registration Number
NCT00876005
Lead Sponsor
Santa Clara Valley Health & Hospital System
Brief Summary

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

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
1202
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1Oxygen by mask80% oxygen during cesarean section
2Oxygen by mask30% oxygen during cesarean section
Primary Outcome Measures
NameTimeMethod
Surgical site infection2 weeks
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Santa clara Valley Medical Center

🇺🇸

San Jose, California, United States

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