Supplemental Oxygen and the Risk of Surgical Site Infection

Perioperative Supplemental Oxygen and the Risk of Surgical Site Infection

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00876005

Acronym

PORSSI

Enrollment

1202

Registered

2009-04-06

Start date

2006-08-31

Completion date

2011-04-30

Last updated

2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

Keywords

Wound infection

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.

Interventions

OTHEROxygen by mask

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Surgical site infection	2 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026