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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

April 3, 2009
April 3, 2009
August 2006
August 2009   (final data collection date for primary outcome measure)
Surgical site infection [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Supplemental Oxygen and the Risk of Surgical Site Infection
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Surgical Site Infection
  • 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%
  • 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%
  • Active Comparator: 1
    80% oxygen during cesarean section
    Intervention: Other: Oxygen by mask
  • Active Comparator: 2
    30% oxygen during cesarean section
    Intervention: Other: Oxygen by mask
Duggal N, Poddatorri V, Noroozkhani S, Siddik-Ahmad RI, Caughey AB. Perioperative oxygen supplementation and surgical site infection after cesarean delivery: a randomized trial. Obstet Gynecol. 2013 Jul;122(1):79-84. doi: 10.1097/AOG.0b013e318297ec6c.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1202
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact: Neena Duggal, MD 408-885-5550 neena.duggal@hhs.sccgov.org
United States
 
NCT00876005
5/11/07-04
Yes
Neena Duggal, MD, Santa Clara Valley Medical Center
Santa Clara Valley Health & Hospital System
Not Provided
Principal Investigator: Neena Duggal, MD Santa Clara Valley Medical Center
Santa Clara Valley Health & Hospital System
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP