Therapeutic effect of ozone therapy on open fracture
Phase 3
- Conditions
- open fracture of Tibial shaft.With or without mention of fracture of fibula
- Registration Number
- IRCT2014012511898N9
- Lead Sponsor
- Vice Chancellor for Research, Guilan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
open fracture of tibia shaft, type IIIa gustilo anderson classification
Exclusion criteria: 1-not having clean wound in firs 48 hour 2-contraindications of ozone therapy including coagulation disorders, organ’s bleeding, allergies to ozone or ozone intolerance, hemorrhagic or apoplectic stroke, G6PD deficiency and interaction with anticoagulants
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method nion of the fracture. Timepoint: First 2 weeks and then monthly until 12 months after permanent fixation. Method of measurement: AP and lateral radiography.
- Secondary Outcome Measures
Name Time Method Infection of wound. Timepoint: First 2 weeks and then monthly until 12 months after permanent fixation. Method of measurement: Localized and systemic signs of infection, lab data include CBC, Diff, ESR and CRP and wound biopsy and calture.;Recovery time. Timepoint: First 2 weeks and then monthly until 12 months after permanent fixation. Method of measurement: Union without infection in AP and lateral radiography.;Knee Score. Timepoint: Measured on admission and 6 and 12 months later. Method of measurement: Knee Score questionnaire.;Ankle Score. Timepoint: Measured on admission and 6 and 12 months later. Method of measurement: Ankle Score questionnaire.