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

October 12, 2016 updated by: Santa Clara Valley Health & Hospital System

Perioperative 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1202

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Jose, California, United States, 95128
        • Santa Clara Valley Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
80% oxygen during cesarean section
Other: Oxygen by mask
Postoperatively, an aerosol face mask is used to deliver oxygen at 80%
Other Names:
  • Face mask delivery of supplemental oxygen at 80%
Other: Oxygen by mask
Postoperatively, an aerosol face mask is used to deliver oxygen at 30%
Other Names:
  • face mask delivery of supplemental oxygen at 30%
Active Comparator: 2
30% oxygen during cesarean section
Other: Oxygen by mask
Postoperatively, an aerosol face mask is used to deliver oxygen at 80%
Other Names:
  • Face mask delivery of supplemental oxygen at 80%
Other: Oxygen by mask
Postoperatively, an aerosol face mask is used to deliver oxygen at 30%
Other Names:
  • face mask delivery of supplemental oxygen at 30%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Surgical site infection
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santa Clara Valley Health & Hospital System

Investigators

  • Principal Investigator: Neena Duggal, MD, Santa Clara Valley Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

April 3, 2009

First Submitted That Met QC Criteria

April 3, 2009

First Posted (Estimate)

April 6, 2009

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5/11/07-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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