This trial is active, not recruiting.

Conditions smoking cessation, fracture
Treatment smoking cessation
Sponsor Karolinska Institutet
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Smoking cessation
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)

Primary Outcomes

Postoperative complications including wound related complications
time frame: 6-12 weeks

Secondary Outcomes

Abstinence rate and functional outcome including HRQoL
time frame: 1 year

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2008.
Information provided to ClinicalTrials.gov by Karolinska Institutet.