Back to resultsSupplemental Oxygen in Vascular Surgery
Primary Purpose
Surgical Wound Infection, Vascular Surgery
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
supplemental postoperative oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Wound Infection
Eligibility Criteria
Inclusion Criteria:
- lower limb vascular surgery
Exclusion Criteria:
- COPD
- sPO2 less than 90%
Sites / Locations
- North Karelia Central Hospital
- Central Finland Central Hospital
- Kuopio University Hospital
- South Karelia Central Hospital
- Central Hospital of Mikkeli
- Lapland Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
1
2
Arm Description
recieves supplemental oxygen postoperatively
treated as usual without supplemental oxygen
Outcomes
Primary Outcome Measures
surgical wound infection
Secondary Outcome Measures
Full Information
NCT ID
NCT00873704
First Posted
March 31, 2009
Last Updated
October 11, 2015
Sponsor
North Karelia Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00873704
Brief Title
Supplemental Oxygen in Vascular Surgery
Official Title
Supplemental Postoperative Oxygen and the Risk of Surgical Wound Infection in a Vascular Surgery Population: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North Karelia Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection, Vascular Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
274 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
recieves supplemental oxygen postoperatively
Arm Title
2
Arm Type
No Intervention
Arm Description
treated as usual without supplemental oxygen
Intervention Type
Other
Intervention Name(s)
supplemental postoperative oxygen
Primary Outcome Measure Information:
Title
surgical wound infection
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
lower limb vascular surgery
Exclusion Criteria:
COPD
sPO2 less than 90%
Facility Information:
Facility Name
North Karelia Central Hospital
City
Joensuu
ZIP/Postal Code
80210
Country
Finland
Facility Name
Central Finland Central Hospital
City
Jyväskylä
ZIP/Postal Code
40620
Country
Finland
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
Facility Name
South Karelia Central Hospital
City
Lappeenranta
ZIP/Postal Code
53130
Country
Finland
Facility Name
Central Hospital of Mikkeli
City
Mikkeli
ZIP/Postal Code
50100
Country
Finland
Facility Name
Lapland Central Hospital
City
Rovaniemi
ZIP/Postal Code
96101
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21476113
Citation
Turtiainen J, Saimanen EI, Partio TJ, Makinen KT, Reinikainen MT, Virkkunen JJ, Vuorio KS, Hakala T. Supplemental postoperative oxygen in the prevention of surgical wound infection after lower limb vascular surgery: a randomized controlled trial. World J Surg. 2011 Jun;35(6):1387-95. doi: 10.1007/s00268-011-1090-y.
Results Reference
derived
Learn more about this trial
Supplemental Oxygen in Vascular Surgery
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