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NCT00876005 Clinical Trial

Supplemental Oxygen and the Risk of Surgical Site Infection

Surgical Site Infection Clinical Trial

— PORSSI  

Official title:
Perioperative Supplemental Oxygen and the Risk of Surgical Site Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00876005
Other study ID # 5/11/07-04
Secondary ID
Status Completed
Phase Phase 4
First received April 3, 2009
Last updated October 12, 2016
Start date August 2006
Est. completion date April 2011

Study information
Verified date May 2016
Source Santa Clara Valley Health & Hospital System
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 1202
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• Oxygen by mask
Postoperatively, an aerosol face mask is used to deliver oxygen at 80%
• Oxygen by mask
Postoperatively, an aerosol face mask is used to deliver oxygen at 30%

Locations
Country Name City State
United States Santa clara Valley Medical Center San Jose California

Sponsors (1)
Lead Sponsor Collaborator
Santa Clara Valley Health & Hospital System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Surgical site infection 2 weeks No
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