Smoking Cessation Intervention in Acute Orthopedic Surgery

NCT ID: NCT00704015

Last Updated: 2008-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2008-06-30

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.

Conditions

Smoking Cessation; Fracture

Keywords

Smoking cessation; Acute injury; Musculoskeletal; Postoperative complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

A

Smoking cessation

Group Type: EXPERIMENTAL

Smoking cessation

Intervention Type: BEHAVIORAL

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.

B

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Karolinska Institutet

Principal Investigators

Sari Ponzer, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Other Identifiers

03-215

Identifier Type: -

Identifier Source: org_study_id