Supplemental Oxygen in Vascular Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00873704
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : October 14, 2015
Information provided by (Responsible Party):
Sanna Kouhia, North Karelia Central Hospital

Brief Summary:
The purpose of this study was to test the hypothesis that supplemental postoperative oxygen reduces the risk of surgical wound infection in patients following lower limb vascular surgery.

Condition or disease Intervention/treatment Phase
Surgical Wound Infection Vascular Surgery Other: supplemental postoperative oxygen Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Supplemental Postoperative Oxygen and the Risk of Surgical Wound Infection in a Vascular Surgery Population: A Randomized Controlled Trial
Study Start Date : March 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
recieves supplemental oxygen postoperatively
Other: supplemental postoperative oxygen
No Intervention: 2
treated as usual without supplemental oxygen

Primary Outcome Measures :
  1. surgical wound infection [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • lower limb vascular surgery

Exclusion Criteria:

  • COPD
  • sPO2 less than 90%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00873704

North Karelia Central Hospital
Joensuu, Finland, 80210
Central Finland Central Hospital
Jyväskylä, Finland, 40620
Kuopio University Hospital
Kuopio, Finland
South Karelia Central Hospital
Lappeenranta, Finland, 53130
Central Hospital of Mikkeli
Mikkeli, Finland, 50100
Lapland Central Hospital
Rovaniemi, Finland, 96101
Sponsors and Collaborators
North Karelia Central Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sanna Kouhia, MD, North Karelia Central Hospital Identifier: NCT00873704     History of Changes
Other Study ID Numbers: NKCH-Surg-003
First Posted: April 2, 2009    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Wound Infection
Surgical Wound
Surgical Wound Infection
Wounds and Injuries
Postoperative Complications
Pathologic Processes