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
The aim of this study was to determine the effects of adding ozone therapy in the treatment of open fractures can be treated with antibiotics. All patients with tibial shaft open fractures type IIIa gustilo anderson classification are enrolled. Debridement, temporary fixation and antibiotic therapy include Cefazolin 2g every 6 hours and gentamicin 80 mg every 12 hours is done in first 8 hours. After 48 hours wound closure and fixation is performed for patients and who do not have clean wound or have contraindications to ozone therapy, are not enrolled. The sample size is 100. Patients were randomly divided into two groups. The first group only underwent surgical debridement and antibiotic treatment practices are above. In addition to these treatments for group II, ozone therapy is done as placing the limb in a plastic bag for 30-20 minutes at a concentration of 5-6 mg / l and minor autohemotherapy on a daily basis for 7 days. For the first group of patients to eliminate the psychological effects of received additional treatment, a similar way to ozone therapy but totally ineffective is performed using air. Patients is seen with orthopedic researcher who is unaware of the division of patients two weeks after surgery and then monthly for 12 months after stabilization surgery. Signs of infection, healing, union, Knee Score and Ankle Score are recorded at each visit.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012511898N9
Registration date:2014-02-05, 1392/11/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-02-05, 1392/11/16
Registrant information
Name
Ahmadreza Mirbolouk
Name of organization / entity
Guilin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 2250
Email address
ah.mirbolouk@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Guilan University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2014-09-22, 1393/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Therapeutic effect of ozone therapy on open fracture
Purpose
Treatment
Inclusion/Exclusion 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
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
Gas field, Ethics Committee of Guilan University of Medical Sciences
City
Rasht
Postal code
41938-93345
Approval date
2013-10-05, 1392/07/13
Ethics committee reference number
1920251610
Health conditions studied
1
Description of health condition studied
open fracture of Tibial shaft
ICD-10 code
S82.2
ICD-10 code description
With or without mention of fracture of fibula
Primary outcomes
1
Description
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 outcomes
1
Description
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
2
Description
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
3
Description
Knee Score
Timepoint
Measured on admission and 6 and 12 months later
Method of measurement
Knee Score questionnaire
4
Description
Ankle Score
Timepoint
Measured on admission and 6 and 12 months later
Method of measurement
Ankle Score questionnaire
Intervention groups
1
Description
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 bag for 30-20 minutes at a concentration of 5-6 mg / l and minor autohemotherapy on a daily basis for 7 days with air for group 1 (control)
Category
Treatment - Other
2
Description
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 minutes at a concentration of 5-6 mg / l and minor autohemotherapy on a daily basis for 7 days with ozone for group 2 (intervention)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina hospital, Guilan University of Medical Sciences
Full name of responsible person
Maral Farahmand
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Guilan University of Medical Sciences
Full name of responsible person
Dr. Abtin Heidarzadeh - Research deputy of Guilan university of medical sciences
Street address
Gas field, Vice Chancellor for Research Guilan University of Medical Sciences
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University of medical sciences
Full name of responsible person
Maral Farahmand
Position
Medical student
Other areas of specialty/work
Street address
Poursina hospital - Orthopaedic Research Center
City
Rasht
Postal code
Phone
+98 13 1322 3970
Fax
Email
maral.farahmand@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of medical sciences
Full name of responsible person
Dr. Ahmadreza Mirbolook
Position
Specialist in Orthopedic Surgery
Other areas of specialty/work
Street address
Poursina hospital - Orthopaedic Research Center
City
Rasht
Postal code
Phone
+98 13 1322 3970
Fax
Email
ahmadreza_mirbolook@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of medical sciences
Full name of responsible person
Maral Farahmand
Position
Medical student
Other areas of specialty/work
Street address
Poursina hospital - Orthopaedic Research Center
City
Rasht
Postal code
Phone
+98 13 1322 3970
Fax
Email
maral.farahmand@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)