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Evaluation the effect of ozone therapy in the treatment of patients with chronic osteomyelitis in orthopedic clinic of PourSina'hospital

Protocol summary

Summary
In orthopedic surgery, osteomyelitis is a rare complication, but annoyingly hard to antibiotic treatment. FDA recently approved for Ozone treatment of osteomyelitis (that resistant to antibiotics). In this study, patients were divided to two groups: 1) treatment with antibiotics, 2) antibiotics and ozone therapy. Redness, swelling , increased ESR and CRP, suspect to osteomyelitis. Bone biopsy and bone culture is used. People with bleeding disorders, those with bleeding organs, people who have allergies or are not tolerate Ozone, Patients with hemorrhagic stroke or Apoplectic, enzyme deficiency G6PD, interact with anticoagulants and those who are in mense period, are excluded in the treatment of. The aim of this study was to determine the effect of Ozone therapy in the treatment of osteomyelitis with antibiotics versus antibiotics alone.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201306276186N2
Registration date: 2013-08-26, 1392/06/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-08-26, 1392/06/04
Registrant information
Name
Bahram Naderi Nabi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3323 4600
Email address
naderi_bahram@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2013-04-22, 1392/02/02
Expected recruitment end date
2013-08-24, 1392/06/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of ozone therapy in the treatment of patients with chronic osteomyelitis in orthopedic clinic of PourSina'hospital
Public title
effect of ozone therapy on the treatment of patients with chronic osteomyelitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: patients with redness and swelling action and increased ESR and CRP ; a bone biopsy involved and culture is positive. Exclusion criteria: people with bleeding disorders, those with bleeding organs; people who are allergic to ozone or can not tolerate it; those with hemorrhagic stroke or Apoplectic; deficiency of the enzyme G6PD; interact with anticoagulants and those who are in mense.
Age
From 14 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Azodi street
City
Rasht
Postal code
4193833697
Approval date
2013-04-20, 1392/01/31
Ethics committee reference number
1920029701

Health conditions studied

1

Description of health condition studied
chronic osteomyelitis
ICD-10 code
M86.3
ICD-10 code description
Chronic multifocal osteomyelitis

Primary outcomes

1

Description
ESR
Timepoint
Before surgery and weekly
Method of measurement
Westergren method, mm/h

2

Description
CRP
Timepoint
Before surgery, then weekly
Method of measurement
Latex agglutination / titration

3

Description
The position involves the disappearance of clinical symptoms
Timepoint
Treatment
Method of measurement
Visual

4

Description
Lesion culture
Timepoint
Debridment time
Method of measurement
In chocolate agar & mac cankey

Secondary outcomes

1

Description
Purulent discharge
Timepoint
Debridment time
Method of measurement
visual

Intervention groups

1

Description
Antibiotic & Ozone thrapy, Ozone 35%, 0.3 micrograms per kg weight every other day
Category
Treatment - Other

2

Description
Antibiotics for 2 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Pain Clinic of Poursina Hospital
Full name of responsible person
Bahram Naderi
Street address
Parastar street
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chanceller,Managment & Resource development Guilan University of Medical Sciences
Full name of responsible person
abdolrasool sobhani
Street address
Emam khomeiny Blv. top of the IRAN Radiator CO.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chanceller,Managment & Resource development 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
Bahram Naderi Nabi
Position
FIPP/assistant proffesor
Other areas of specialty/work
Street address
Pain clinic of Poursina Hospital
City
Rasht
Postal code
41937-13194
Phone
+98 13 1321 0434
Fax
+98 13 1323 9843
Email
naderi_baghram@gums.ac.ir; ARC@gums.ac.ir; vbuh.research@gmail.com
Web page address
www.gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Bahram Naderi
Position
FIPP/Assistant proffesor
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
41937-13194
Phone
+98 13 1321 0434
Fax
+98 13 1324 5132
Email
naderi_bahram@gums.ac.ir;ARC@gums.ac.ir; vbuh.research@gmail.com
Web page address
www.gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedieh Nemati
Position
BA / medical lab sciences
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
41937-13194
Phone
+98 13 1321 0434
Fax
+98 13 1323 9842
Email
naderi_bahram@gums.ac.ir; ARC@gums.ac.ir; vbuh.research@gmail.com;h_n_112@gmail.com
Web page address
www.gums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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