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

Primary Purpose

Surgical Site Infection

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oxygen by mask
Oxygen by mask
Sponsored by
Santa Clara Valley Health & Hospital System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring Wound infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Santa clara Valley Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

80% oxygen during cesarean section

30% oxygen during cesarean section

Outcomes

Primary Outcome Measures

Surgical site infection

Secondary Outcome Measures

Full Information

First Posted
April 3, 2009
Last Updated
October 12, 2016
Sponsor
Santa Clara Valley Health & Hospital System
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1. Study Identification

Unique Protocol Identification Number
NCT00876005
Brief Title
Supplemental Oxygen and the Risk of Surgical Site Infection
Acronym
PORSSI
Official Title
Perioperative Supplemental Oxygen and the Risk of Surgical Site Infection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Santa Clara Valley Health & Hospital System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a study to see whether increasing the oxygen concentration during and after a cesarean section decreases the infection rate.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
Wound infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1202 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
80% oxygen during cesarean section
Arm Title
2
Arm Type
Active Comparator
Arm Description
30% oxygen during cesarean section
Intervention Type
Other
Intervention Name(s)
Oxygen by mask
Other Intervention Name(s)
Face mask delivery of supplemental oxygen at 80%
Intervention Description
Postoperatively, an aerosol face mask is used to deliver oxygen at 80%
Intervention Type
Other
Intervention Name(s)
Oxygen by mask
Other Intervention Name(s)
face mask delivery of supplemental oxygen at 30%
Intervention Description
Postoperatively, an aerosol face mask is used to deliver oxygen at 30%
Primary Outcome Measure Information:
Title
Surgical site infection
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neena Duggal, MD
Organizational Affiliation
Santa Clara Valley Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa clara Valley Medical Center
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23743467
Citation
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. Erratum In: Obstet Gynecol. 2013 Sep;122(3):698. Ppddatorri, Vineela [corrected to Poddatoori, Vineela].
Results Reference
derived

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Supplemental Oxygen and the Risk of Surgical Site Infection

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