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Supplemental Oxygen in Vascular Surgery

This study has been completed.
Sponsor:
Information provided by:
North Karelia Central Hospital
ClinicalTrials.gov Identifier:
NCT00873704
First received: March 31, 2009
Last updated: November 19, 2010
Last verified: March 2009
History of Changes
  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 Blind (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:

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Further study details as provided by North Karelia Central Hospital:

Primary Outcome Measures:
  • surgical wound infection [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • lower limb vascular surgery

Exclusion Criteria:

  • COPD
  • sPO2 less than 90%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by North Karelia Central Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johanna Turtiainen, Head of the department of vascular surgery, North Karelia Central hospital
ClinicalTrials.gov Identifier: NCT00873704     History of Changes
Other Study ID Numbers: NKCH-Surg-003
Study First Received: March 31, 2009
Last Updated: November 19, 2010
Health Authority: Finland: North Karelia central hospital department of vascular surgery

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

ClinicalTrials.gov processed this record on May 22, 2013