Smoking Cessation Intervention in Acute Orthopedic Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Karolinska Institutet.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00704015
First received: June 23, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

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 Intervention
Smoking Cessation
Fracture
Behavioral: Smoking cessation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Smoking Cessation Intervention in Acute Orthopedic Surgery - A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Postoperative complications including wound related complications [ Time Frame: 6-12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Abstinence rate and functional outcome including HRQoL [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: February 2004
Estimated Study Completion Date: June 2008
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704015

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

No publications provided

Responsible Party: Sari Ponzer. MD, Prof, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00704015     History of Changes
Other Study ID Numbers: 03-215
Study First Received: June 23, 2008
Last Updated: June 23, 2008
Health Authority: Sweden: Regional Ethical Review Board

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

Additional relevant MeSH terms:
Fractures, Bone
Smoking
Wounds and Injuries
Habits

ClinicalTrials.gov processed this record on April 15, 2014