Smoking Cessation Intervention in Acute Orthopedic Surgery

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00704015
• Other study ID #: 03-215
• Status: Active, not recruiting
• Phase: N/A
• First received: June 23, 2008
• Last updated: June 23, 2008
• Start date: February 2004
• Est. completion date: June 2008

Study information

• Verified date: June 2008
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: June 2008
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fracture
• Smoking Cessation

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications including wound related complications		6-12 weeks	No
Secondary	Abstinence rate and functional outcome including HRQoL		1 year	No