Effect of Tobacco Heating System (THS) on Closed Lower Limb Fracture Healing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Tuebingen
About this trial
The goal of this clinical trial is to investigate the role of switching from cigarette smoking (CS) to tobacco heat system (THS) on the clinical outcome of closed lower limb (tibia and femur) fractures from smokers' orthopedic patients. Validated and standardized assays, medical state and self-reported outcomes will be evaluated in orthopedic patients' smokers or switch from CS to using THS throughout six months compare to ex-smokers (control).
Eligibility criteria
Qualifiers
Closed tibia or femur fracture (according to AO/OTA: 41A2-41C3, 42A-C, 43A-C, 32A-C, 33A2-3, 33B-C) which is surgically treated within 14 days after the trauma at the BG trauma clinic Tübingen.
Smokers with 10-20 packyears smoking history.
Smoking history >10 years.
Decision not to participate in the free smoking cessation seminars.
Disqualifiers
Legal guardian or loss of capacity to consent.
Refusal to participate in the study.
Open fractures or concomitant injuries or complications requiring surgery existing at the time of surgical indication.
Initial surgical treatment of the fracture has occurred ex domo.
Trial design
Treatments tested in this trial
- Tobacco Heating System (THS)
- Smoking abstinence
Treatment groups
150 Participants
are divided into 3 treatment groupsSponsors and collaborators
University Hospital Tuebingen
Lead sponsor
Philip Morris Products S.A.
Collaborator
Source ClinicalTrials.gov