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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Santa Clara Valley Health & Hospital System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Santa Clara Valley Health & Hospital System
ClinicalTrials.gov Identifier:
NCT00876005
First received: April 3, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1202
Study Start Date: August 2006
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876005

Contacts
Contact: Neena Duggal, MD 408-885-5550 neena.duggal@hhs.sccgov.org

Locations
United States, California
Santa clara Valley Medical Center Recruiting
San Jose, California, United States, 95128
Contact: Neena Duggal, MD    408-885-5550    neena.duggal@hhs.sccgov.org   
Sub-Investigator: Carter Cherry, MD         
Sponsors and Collaborators
Santa Clara Valley Health & Hospital System
Investigators
Principal Investigator: Neena Duggal, MD Santa Clara Valley Medical Center
  More Information

No publications provided by Santa Clara Valley Health & Hospital System

Additional 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
Study First Received: April 3, 2009
Last Updated: April 3, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Infection
Communicable Diseases

ClinicalTrials.gov processed this record on September 18, 2014