- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00873704
Supplemental Oxygen in Vascular Surgery
October 11, 2015 updated by: Sanna Kouhia, North Karelia Central Hospital
Supplemental Postoperative Oxygen and the Risk of Surgical Wound Infection in a Vascular Surgery Population: A Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
274
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Joensuu, Finland, 80210
- North Karelia Central Hospital
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Jyväskylä, Finland, 40620
- Central Finland Central Hospital
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Kuopio, Finland
- Kuopio University Hospital
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Lappeenranta, Finland, 53130
- South Karelia Central Hospital
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Mikkeli, Finland, 50100
- Central Hospital of Mikkeli
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Rovaniemi, Finland, 96101
- Lapland Central Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 110 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- lower limb vascular surgery
Exclusion Criteria:
- COPD
- sPO2 less than 90%
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
recieves supplemental oxygen postoperatively
|
|
No Intervention: 2
treated as usual without supplemental oxygen
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
surgical wound infection
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
March 31, 2009
First Submitted That Met QC Criteria
March 31, 2009
First Posted (Estimate)
April 2, 2009
Study Record Updates
Last Update Posted (Estimate)
October 14, 2015
Last Update Submitted That Met QC Criteria
October 11, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NKCH-Surg-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on supplemental postoperative oxygen
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-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health... and other collaboratorsNot yet recruitingGlucose Intolerance | Sleep-Disordered Breathing
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University of UtahCompletedPatient Monitoring | Oxygen Delivery | Patient ComfortUnited States
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Santa Clara Valley Health & Hospital SystemCompletedSurgical Site InfectionUnited States
-
Brigham and Women's HospitalNational Heart, Lung, and Blood Institute (NHLBI); American Heart AssociationCompleted
-
University of ZurichActive, not recruitingPulmonary Artery Hypertension | Chronic Thromboembolic Pulmonary Hypertension | Pulmonary Vascular DisorderSwitzerland
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Ullevaal University HospitalCompleted