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Supplemental Oxygen in Vascular Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00873704
First Posted: April 2, 2009
Last Update Posted: October 14, 2015
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.
Information provided by (Responsible Party):
Sanna Kouhia, North Karelia Central Hospital
  Purpose
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 Intervention
Surgical Wound Infection Vascular Surgery Other: supplemental postoperative oxygen

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sanna Kouhia, North Karelia Central Hospital:

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

Enrollment: 274
Study Start Date: March 2009
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
recieves supplemental oxygen postoperatively
Other: supplemental postoperative oxygen
No Intervention: 2
treated as usual without supplemental oxygen

  Eligibility

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
Criteria

Inclusion Criteria:

  • lower limb vascular surgery

Exclusion Criteria:

  • COPD
  • sPO2 less than 90%
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00873704


Locations
Finland
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanna Kouhia, MD, North Karelia Central Hospital
ClinicalTrials.gov Identifier: NCT00873704     History of Changes
Other Study ID Numbers: NKCH-Surg-003
First Submitted: March 31, 2009
First Posted: April 2, 2009
Last Update Posted: October 14, 2015
Last Verified: October 2015

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