Supplemental Oxygen and the Risk of Surgical Site Infection (PORSSI)

Santa Clara Valley Health & Hospital System

Status and phase: Completed; Phase 4

Conditions: Surgical Site Infection

Treatments: Other: Oxygen by mask

Study type: Interventional

Funder types: Other

Identifiers

NCT00876005

5/11/07-04

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,202 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,202 participants in 2 patient groups

1

Active Comparator group

Description:

80% oxygen during cesarean section

Treatment:

Other: Oxygen by mask

Other: Oxygen by mask

2

Active Comparator group

Description:

30% oxygen during cesarean section

Treatment:

Other: Oxygen by mask

Other: Oxygen by mask