Evaluation of Iranian hydrogel on repair of burned skin
Patients with grade two burn include in research, fewer than 10 and over 50 years old, specific area such: head, neck, axilla and perinea, patient with inflammatory disease and cases more than 24 hours last from burn excluded.
Patients randomly divided in three groups, first with conventional dressing and two others with Iranian gel and Maxgel dressed in each group with 30 patients.
The patients dressing continued until complete repair every other day. Severity of pain while dressing, remission rate and infection of skin will be measured and compared in three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902123853N1
Registration date:2012-06-02, 1391/03/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-02, 1391/03/13
Registrant information
Name
Mohamad Taghi Noorbala
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1525 0094
Email address
noorbala@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Radiation Application Research School
Expected recruitment start date
2010-06-01, 1389/03/11
Expected recruitment end date
2011-06-01, 1390/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of Iranian hydrogel with Maxgel and conventional dressing in the treatment of second degree burn in shahid sadoughi burn hospital
Public title
Evaluation of efficacy and safety of Iranian Hydrogel in burn
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: only grad two skin burn
Exclusion criteria: burned surface more than 10%; axillary, groin, perinea, head and neck burn lasted more than 24h;
Known immuno-compromised patients; patients with known systemic inflammatory disease.
Age
From 10 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
No
Secondary trial Id
No
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid Sadoughi Medical sciences University
Street address
Bahonar Square No. 1 Bulding of SSU, Yazd
City
Yazd
Postal code
Approval date
2009-01-11, 1387/10/22
Ethics committee reference number
94895
Health conditions studied
1
Description of health condition studied
Second Stage of Burning
ICD-10 code
T22
ICD-10 code description
Burn and corrosion of shoulder and upper limb, except wrist and hand
2
Description of health condition studied
Second Stage of Burning
ICD-10 code
T23
ICD-10 code description
Burn and corrosion of wrist and hand
3
Description of health condition studied
Second stage of burning
ICD-10 code
T21
ICD-10 code description
Burn and corrosion of trunk
4
Description of health condition studied
Second Stage of Burning
ICD-10 code
T24
ICD-10 code description
Burn and corrosion of hip and lower limb, except ankle and foot
5
Description of health condition studied
Second Stage of Burning
ICD-10 code
T25
ICD-10 code description
Burn and corrosion of ankle and foot
Primary outcomes
1
Description
Repair of burned surface
Timepoint
Every other day
Method of measurement
masurement of burn surface by ruler
Secondary outcomes
1
Description
Pain in dressing time
Timepoint
every other day
Method of measurement
Visual scale
Intervention groups
1
Description
Dressing of burned skin in all groups continued untile complete remission every other day. Group one dressing as conventional mode with gas vaselin and silver sulfadiazin cream, in group two dressing with Iranian hydrogel (Product of Radiation Application Research School) and third group dressing with Maxgel ( product of Fordgel company of hong-kong).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoghi Burn Hospital
Full name of responsible person
Mohamad Taghi Noorbala
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd Radiation Application Research School
Full name of responsible person
Mohamad Ali Taghavi Zade Ardakani
Street address
15 Km Yazd -Taft Road
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Radiation Application Research School
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
Shahid Sadoughi Medical Sciences University
Full name of responsible person
Mohamad Taghi Noorbala
Position
Associate Professor of Dermatology
Other areas of specialty/work
Street address
22 Bahman Blv, Shahid Sadoughi Burn Hospital
City
Yazd
Postal code
Phone
+98 35 1525 0094
Fax
Email
noorbala@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi Medical Sciences University
Full name of responsible person
Mohamad Taghi Noorbala
Position
Associate Professor of Dermatology
Other areas of specialty/work
Street address
22 Bahman Blv, Shahid Sadoughi Burn Hospital
City
Yazd
Postal code
Phone
+98 35 1525 0094
Fax
Email
noorbala@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi Medical Sciences University
Full name of responsible person
Mohamad Taghi Noorbala
Position
Associate Professor of Dermatology
Other areas of specialty/work
Street address
22 Bahman Blv, Shahid Sadoughi Burn Hospital
City
Yazd
Postal code
Phone
+98 35 1525 0094
Fax
Email
noorbala@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)