Therapeutic effect of ozone therapy on open fracture

Evaluation and comparison the complications and cure of open fracture of Tibia anti-biotic treatment with debridement and additional ozone therapy by clinical trial study design

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014012511898N9

Enrollment

100

Registered

2014-02-05

Start date

2014-03-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

open fracture of Tibial shaft. With or without mention of fracture of fibula

Interventions

Intervention 1: Debridement, Antibiotic therapy include Cefazolin 2g every 6 hours and gentamicin 80 mg every 12 hours is done in first 8 hours and similar way to ozone therapy include placing the lim

Treatment - Other

Debridement, Antibiotic therapy include Cefazolin 2g every 6 hours and gentamicin 80 mg every 12 hours is done in first 8 hours and similar way to ozone therapy include placing the limb in a plastic b

Debridement, Antibiotic therapy include Cefazolin 2g every 6 hours and gentamicin 80 mg every 12 hours is done in first 8 hours and ozone therapy include placing the limb in a plastic bag for 30-20 mi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Union of the fracture. Timepoint: First 2 weeks and then monthly until 12 months after permanent fixation. Method of measurement: AP and lateral radiography.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaral Farahmand

Guilan University of medical sciences

maral.farahmand@gmail.com+98 13 1322 3970

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026