Smoking Cessation Intervention in Acute Orthopedic Surgery
This trial is active, not recruiting.
|Conditions||smoking cessation, fracture|
|Collaborator||Stockholm County Council, Sweden|
|Start date||February 2004|
|End date||December 2006|
|Trial size||105 participants|
|Trial identifier||NCT00704015, 03-215|
The purpose of this study was to evaluate if an intervention with smoking cessation starting during the acute hospitalization period and continuing during the acute postoperative phase of 6 weeks would reduce the frequency of overall postoperative complications and wound infections in patients with acute musculoskeletal injuries requiring surgical treatment. The secondary aims were to study the short and the long term (1 year) abstinence rate, functional outcome, health related quality of life as well as costs.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Postoperative complications including wound related complications
time frame: 6-12 weeks
Abstinence rate and functional outcome including HRQoL
time frame: 1 year
Male or female participants from 18 years up to 90 years old.
Inclusion Criteria: - daily smoker: more than 2 cigarettes per day for at least one year - acute fracture of an extremity, in need of surgical treatment - oral and written consent Exclusion Criteria: - pregnancy - alcohol or drug abuse prohibiting compliance with the study protocol - living outside the county of Stockholm prohibiting follow-up - a severe mental illness including dementia - inability to read and understand Swedish
|Official title||Smoking Cessation Intervention in Acute Orthopedic Surgery - A Randomized Controlled Trial|
|Principal investigator||Sari Ponzer, MD, Prof|
|Description||Tobacco smoking is a major health problem. The effect of a smoking cessation intervention prior to elective orthopedic surgery has been evaluated previously. However, as far as we know there are no prospective randomized studies investigating the effect of smoking cessation on complication rate in patients with acute musculoskeletal injuries.|
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