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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00876005
First Posted: April 6, 2009
Last Update Posted: October 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Santa Clara Valley Health & Hospital System
  Purpose
This is a study to see whether increasing the oxygen concentration during and after a cesarean section decreases the infection rate.

Condition Intervention Phase
Surgical Site Infection Other: Oxygen by mask Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Perioperative Supplemental Oxygen and the Risk of Surgical Site Infection

Resource links provided by NLM:


Further study details as provided by Santa Clara Valley Health & Hospital System:

Primary Outcome Measures:
  • Surgical site infection [ Time Frame: 2 weeks ]

Estimated Enrollment: 1202
Study Start Date: August 2006
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Face mask delivery of supplemental oxygen at 80%
Active Comparator: 2
30% oxygen during cesarean section
Other: Oxygen by mask
Postoperatively, an aerosol face mask is used to deliver oxygen at 30%
Other Name: face mask delivery of supplemental oxygen at 30%

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00876005


Locations
United States, California
Santa clara Valley Medical Center
San Jose, California, United States, 95128
Sponsors and Collaborators
Santa Clara Valley Health & Hospital System
Investigators
Principal Investigator: Neena Duggal, MD Santa Clara Valley Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Neena Duggal, MD, Santa Clara Valley Medical Center
ClinicalTrials.gov Identifier: NCT00876005     History of Changes
Other Study ID Numbers: 5/11/07-04
First Submitted: April 3, 2009
First Posted: April 6, 2009
Last Update Posted: October 13, 2016
Last Verified: May 2016

Keywords provided by Santa Clara Valley Health & Hospital System:
Wound infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes