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Smoking Cessation Intervention in Acute Orthopedic Surgery

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ClinicalTrials.gov Identifier: NCT00704015
Recruitment Status : Unknown
Verified June 2008 by Karolinska Institutet.
Recruitment status was:  Active, not recruiting
First Posted : June 24, 2008
Last Update Posted : June 24, 2008
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by:
Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Fracture Behavioral: Smoking cessation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Smoking Cessation Intervention in Acute Orthopedic Surgery - A Randomized Controlled Trial
Study Start Date : February 2004
Actual Primary Completion Date : December 2006
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Smoking cessation
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



Primary Outcome Measures :
  1. Postoperative complications including wound related complications [ Time Frame: 6-12 weeks ]

Secondary Outcome Measures :
  1. Abstinence rate and functional outcome including HRQoL [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704015


Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Investigators
Principal Investigator: Sari Ponzer, MD, Prof Karolinska Institutet

Responsible Party: Sari Ponzer. MD, Prof, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00704015     History of Changes
Other Study ID Numbers: 03-215
First Posted: June 24, 2008    Key Record Dates
Last Update Posted: June 24, 2008
Last Verified: June 2008

Keywords provided by Karolinska Institutet:
Smoking cessation
Acute injury
Musculoskeletal
Postoperative complications