Smoking Cessation Intervention in Acute Orthopedic Surgery

NCT00704015 | Unknown

• 1 other identifier: 03-215
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Smoking Cessation; Fracture

Keywords

Smoking cessation; Acute injury; Musculoskeletal; Postoperative complications

Outcome Measures

Primary Outcomes (1)

• Postoperative complications including wound related complications

  6-12 weeks

Secondary Outcomes (1)

• Abstinence rate and functional outcome including HRQoL

  1 year

Study Arms (2)

A

EXPERIMENTAL

Smoking cessation

Behavioral: Smoking cessation

B

NO INTERVENTION

Interventions

Smoking cessation 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.

A

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

MeSH Terms

Conditions

Smoking Cessation; Fractures, Bone; Postoperative Complications

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sari Ponzer, MD, Prof

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 24, 2008
• Study Start: February 1, 2004
• Primary Completion: December 1, 2006
• Study Completion: June 1, 2008
• Last Updated: June 24, 2008

Record last verified: 2008-06