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Clinical Trials/NCT00704015
NCT00704015
Unknown
Not Applicable

Smoking Cessation Intervention in Acute Orthopedic Surgery - A Randomized Controlled Trial

Karolinska Institutet0 sites105 target enrollmentFebruary 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Smoking Cessation
Sponsor
Karolinska Institutet
Enrollment
105
Primary Endpoint
Postoperative complications including wound related complications
Last Updated
17 years ago

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
February 2004
End Date
June 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Postoperative complications including wound related complications

Time Frame: 6-12 weeks

Secondary Outcomes

  • Abstinence rate and functional outcome including HRQoL(1 year)

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