Determination and comparison of adhesion and stem cell growth in the two groups.
Design
In order to conduct the present study, 15 people with skin lesions and wounds will be selected.
The results will be compared between different groups using statistical software and ANOVA statistical analysis.
Settings and conduct
The skin matrix transplant will be performed by a dermatologist. All subjects will be informed of the study and a written informed consent form, based on the principles of medical ethics, will be completed by them.
Sample selection - Preparation of cellular scaffold - Review of prepared cellular scaffold.
Participants/Inclusion and exclusion criteria
Inclusion criteria include the absence of underlying diseases, the absence of autoimmune diseases, the absence of hypertension, the absence of diabetes and the willingness to participate in the study and complete the questionnaire and written informed consent. Also, people with underlying diseases, autoimmunity, high blood pressure, diabetes, etc. will be excluded from the study.
Intervention groups
We have 2 intervention groups, one group including healthy skin as the control group and one group with burns that will be transplanted as the intervention group.
Main outcome variables
1. Acellular scaffolding
2. Scaffold toxicity
3. The degree of adhesion of cells to the scaffold
4. Prepared scaffold matrix
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210112050019N1
Registration date:2021-08-24, 1400/06/02
Registration timing:retrospective
Last update:2021-08-24, 1400/06/02
Update count:0
Registration date
2021-08-24, 1400/06/02
Registrant information
Name
Leyla Roshangar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 3870
Email address
roshangarl@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-16, 1400/03/26
Expected recruitment end date
2021-06-26, 1400/04/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of the acellular dermal matrix on skin wound healing: A pilot clinical trial study
Public title
Effects of the acellular dermal matrix on skin wound healing: A pilot clinical trial study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with second-degree burns.
Exclusion criteria:
Existence of autoimmune diseases
Existence of high blood pressure
Existence of diabetes
Age
No age limit
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
Balanced blocked randomization (BBR) (Block size=4) will be used in the present study to assign the individuals to the intervention (receiving acellular dermal matrix) and control groups, respectively. The sequences generated by BBR using Random Allocation Software (RAS) will be preserved by epidemiologist and it will not be accessible/predictable for other individual involved in the study. Hence, allocation concealment will be assured. Notably, 15 individuals will be included into the each group and effectiveness of BBR on balancing the distribution of potential confounders across the study groups will be assessed.
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
Tabriz Ethics Committee of Medical Sciences
Street address
Azadi St., next to Imam Reza Hospital, Tabriz University of Medical Sciences
City
tabriz
Province
East Azarbaijan
Postal code
51738-15992
Approval date
2021-05-31, 1400/03/10
Ethics committee reference number
IR.TBZMED.REC.1400.248
Health conditions studied
1
Description of health condition studied
The effect of acellular skin matrix on skin wound healing
ICD-10 code
L99
ICD-10 code description
Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
Primary outcomes
1
Description
Percentage of people who have burns
Timepoint
Healing of skin ulcers at the beginning of the study and 21 days after the start of the clinical trial
Method of measurement
Skin Wound Healing Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People with skin lesions due to burns, skin injuries, scar tissue caused by injuries. Initially, the cellular scaffold was prepared from the intestine and for disinfection and desullarization for 2 hours of prastic acid ./1% (C2H4O3 )And 4% ethanol (C2H5OH) and 96% distilled water were used and finally the cellular scaffold was washed twice with saline phosphate buffer (PBS) and twice with distilled water. They are the manufacturer of Iranian consumables, then in the culture plate. Cell (DMEM) was placed to culture the cells, after which the dermatologist attached the cell fragments to the areas with skin lesions once to evaluate the results.
Category
Treatment - Surgery
2
Description
Control group: Does not receive any intervention.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital, Tabriz
Full name of responsible person
Dr. Mohammad Reza Ranjkesh
Street address
Azadi Street - not reached Maralan
City
tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3541 2101
Email
reza.se7en77@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Leila Roshanghar
Street address
Azadi St., Corner of Imam Reza Hospital, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3336 3870
Fax
+98 41 3335 9870
Email
Reza.Se7en77@yahoo.com
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.Leila Roshanghar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Histology
Street address
Azadi St., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 3870
Email
lroshangar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Leila Roshangar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Histology
Street address
Azadi St., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 3870
Email
lroshangar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Leila Roshanghar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Histology
Street address
Azadi St., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 3870
Email
lroshangar@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
By publishing an article
When the data will become available and for how long
Start access after 3 months of printing results
To whom data/document is available
Researchers and professors of all universities
Under which criteria data/document could be used
They are allowed access if there is no scientific theft
From where data/document is obtainable
If the article is published via email to the responsible author
What processes are involved for a request to access data/document
In the shortest possible time after contacting the responsible author