Smoking Cessation Intervention in Acute Orthopedic Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Smoking Cessation, Fracture

Intervention / Treatment
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* Behavioral: Smoking cessation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Smoking cessation | Behavioral: Smoking cessation<br>* Nurses, specifically trained for smoking cession program, contacted the patients at the orthopedic wards and initiated the intervention (stop smoking) within 1-2 days after acute hospitalization. The intervention included one or two personal meetings and weekly phone contacts during 6 weeks with a trained nurse. A phone number to a non-smoking hotline was provided for all patients. The patients were continuously encouraged not to smoke and free nicotine substitution (Nicorette®) was offered those who needed it. No other drug therapy was used.<br>|
| No Intervention: B<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications including wound related complications |  | 6-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence rate and functional outcome including HRQoL |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation, Acute injury, Musculoskeletal, Postoperative complications