Smoking Cessation Intervention in Acute Orthopedic Surgery
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Smoking Cessation Intervention in Acute Orthopedic Surgery - A Randomized Controlled Trial|
- Postoperative complications including wound related complications [ Time Frame: 6-12 weeks ] [ Designated as safety issue: No ]
- Abstinence rate and functional outcome including HRQoL [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||February 2004|
|Estimated Study Completion Date:||June 2008|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
Behavioral: Smoking cessation
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.
|No Intervention: B|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704015
|Principal Investigator:||Sari Ponzer, MD, Prof||Karolinska Institutet|