Supplemental Oxygen and the Risk of Surgical Site Infection

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

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Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Santa clara Valley Medical Center

San Jose, California, 95128, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen by mask

Other

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

Other names: Face mask delivery of supplemental oxygen at 80%

Primary outcomes

Surgical site infection

Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Santa Clara Valley Health & Hospital System

Other

Registry information

Official study title

Perioperative Supplemental Oxygen and the Risk of Surgical Site Infection

Acronym: PORSSI

Important dates

Study start: 2006
Primary completion: 2011
Study completion: 2011
First posted: Apr 6, 2009
Registry last updated: Oct 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed