Comparison of efficacy of autologous epidermal cell suspension and silver sulfadiazine ointment in treatment of second degree burn
Design
20 patients whom are burned as second degree at 2 different areas of their body will be included according to inclusion, exclusion criteria. On an area silver sulfadiazine ointment and on other one epidermal cell suspension will be applied. the study is not blinded and randomized allocation is not applied.
Settings and conduct
As the routine treatment of the second degree burns, we will apply silver sulfadiazine ointment every 12 hours for whole burns except the area which will be treated by epidermal cell suspension. one milliliter of the provided epidermal cell suspension is transferred to 2×2 cm of the burned area by a pipette. Then it will be compressed by a silicon mesh and a wet woven gauze and covered by a semipermeable tegaderm film. The dressing will be removed every 5 days up to 20 days and the areas will be evaluated by experienced specialist in the burns ward of Sina hospital of Tabriz University of Medical Science for reepithelization and complications. the photographs of both treated areas by silversulfadiazin and epidermal cell suspension will be obtained and finally will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All the patients who are second degree burned in at least 2 different areas of their body, admitted in Sina hospital and have no more comorbidities.
Exclusion criteria:
Pregnancy
Milking
Immunocompromised
Unwilling to participate
Intervention groups
All the patients whom are burned as second degree in at least 2 different areas of their body
Main outcome variables
The percent of epithelialized skin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140705018373N2
Registration date:2018-03-29, 1397/01/09
Registration timing:registered_while_recruiting
Last update:2018-03-29, 1397/01/09
Update count:0
Registration date
2018-03-29, 1397/01/09
Registrant information
Name
Mohamad Reza Ranjkesh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 116 5061
Email address
ranjkeshm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-10-07, 1397/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of autologous epidermal cell suspension and silver sulfadiazine ointment in treatment of second degree burn
Public title
Autologous epidermal cells and second degree burn
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients who are burned in 2 different areas, admitted at Sina hospital and have no more comorbidities.
Exclusion criteria:
Pregnancy
Milking
Immunocompromised
unwilling to participate
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Sina hospital, Azadi Ave., Tabriz town, East Azarbyjan
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Approval date
2018-01-02, 1396/10/12
Ethics committee reference number
Ir.tbzmed.rec.1396.833
Health conditions studied
1
Description of health condition studied
Second degree burn
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The percent of reepithelization of second degree burned skin
Timepoint
Before the intervention initiation, every 5 days till 20 days and 2 months later
Method of measurement
By photograph
Secondary outcomes
1
Description
Scar
Timepoint
2 months after intervention
Method of measurement
By photograph
Intervention groups
1
Description
Intervention group: The patients with at least two second degree burn areas on their body
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr. Mohammadreza Ranjkesh
Street address
Sina hospital, Azadi Ave., Tabriz town, East Azarbyjan
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
ranjkeshm@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Ranjkesh
Street address
Sina hospital, Azadi Ave., Tbriz town, East Azarbyjan
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
ranjkeshm@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohmmadreza Ranjkesh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi Ave., Tabriz town, East Azarbyjan
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
ranjkeshm@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Ranjkesh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi Ave., Tabriz town, East Azarbyjan
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
ranjkeshm@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Ranjkesh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi Ave., Tabriz town, East Azarbyjan
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
ranjkeshm@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available