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

This study has been completed.
Sponsor:
Information provided by:
Santa Clara Valley Health & Hospital System
ClinicalTrials.gov Identifier:
NCT00876005
First received: April 3, 2009
Last updated: October 12, 2016
Last verified: May 2016
April 3, 2009
October 12, 2016
August 2006
April 2011   (Final data collection date for primary outcome measure)
Surgical site infection [ Time Frame: 2 weeks ]
Same as current
Complete list of historical versions of study NCT00876005 on ClinicalTrials.gov Archive Site
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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 (Participant, Care Provider, 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, Poddatoori 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. Erratum in: Obstet Gynecol. 2013 Sep;122(3):698. Ppddatorri, Vineela [corrected to Poddatoori, Vineela].

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1202
April 2011
April 2011   (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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00876005
5/11/07-04
Yes
Not Provided
Not Provided
Not Provided
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
May 2016

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