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

S

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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