This is a clinical trial study to assess the effect of using adipose-derived stem cells in improving trauma, surgical and burn induced hypertrophic scars. For this purpose we include patients from Fatemeh Hospital with hypertrophic scar due to trauma, burn or surgery after obtaining written informed consent and informing about the method of study with convenience sampling method. In the initial phase of this study, first we do liposuction of periumbilical region with local anesthesia as an outpatient procedure, and then fat derived stem cells, after culture and cell characterization, are sent to the research executive. Photos will be taken of all scars before any intervention and will be scored with Vancouver scoring system. The scar is divided into two equal halves. We inject normal saline in one half and fat derived stem cells in the other half with the same volumes. Patients will be examined at 3, 6 months and 1 year after injection, taken photos and their scars will be scored.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012070710201N1
Registration date:2012-10-04, 1391/07/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-10-04, 1391/07/13
Registrant information
Name
Ali asghar Salahi kojoor
Name of organization / entity
Iran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 2640 8735
Email address
a-abbaszadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical scinces
Expected recruitment start date
2012-10-06, 1391/07/15
Expected recruitment end date
2013-03-05, 1391/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of assessing the effect of using adipose-derived stem cells in improving trauma, surgical and burn induced hypertrophic scars
Public title
The role of stem cells in hypertrophic scar improvement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with hypertrophic scar. Exclusion criteria: Patient's reluctance to continue cooperation.
Age
No age limit
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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University Of Medical Sciences
Street address
Tehran University Of Medical Sciences, Hemat campus, Hemat High Way
City
Tehran
Postal code
Approval date
2012-08-07, 1391/05/17
Ethics committee reference number
9003121493162041
Health conditions studied
1
Description of health condition studied
Hypertrophic Scar
ICD-10 code
L91.0
ICD-10 code description
Hypertrophic scar
Primary outcomes
1
Description
Vascularity
Timepoint
3, 6 months and 1 year
Method of measurement
Inspection
2
Description
Pigmentation
Timepoint
3 , 6 months and 1 year
Method of measurement
Inspection
3
Description
pliability
Timepoint
3 , 6 months and 1 year
Method of measurement
palpation
4
Description
Height
Timepoint
3 , 6 months and 1 year
Method of measurement
Measurement with caliper
5
Description
Vancouver Scoring System
Timepoint
3 , 6 months and 1 year
Method of measurement
Inspection and Palpation
Secondary outcomes
1
Description
Scar Tissue Increment
Timepoint
3 , 6 months and 1 year
Method of measurement
Inspection and measurment with caliper
2
Description
Pruritus
Timepoint
3 , 6 months and 1 year
Method of measurement
Patient Expression
3
Description
Burning
Timepoint
3 , 6 months and 1 year
Method of measurement
Patient Expression
4
Description
Injection Site Infection and Inflammation
Timepoint
Up to 1 month
Method of measurement
Diagnosis by physician
Intervention groups
1
Description
0.5 cc N/S injection per 1 square Cm of controls scar
Category
Placebo
2
Description
0.5 cc fat derived stem cell injection per 1 square cm of cases scar
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Fatemeh Hospital
Full name of responsible person
Abolfazl Abbaszadeh
Street address
21st st. Yousefabad
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Pour sina Ave, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University Of Medical Sciences
Full name of responsible person
Abolfazl Abbaszadeh
Position
Plastic Surgery Resident
Other areas of specialty/work
Street address
21st st. Yousefabad, Hazrat Fatemeh Hospital
City
Tehran
Postal code
Phone
+98 21 8871 0099
Fax
Email
a-abbaszadeh@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Aliasghar Salahi kojoor
Position
Plastic Surgery Resident
Other areas of specialty/work
Street address
21st st. Yousefabad, Hazrat Fatemeh Hospital
City
Tehran
Postal code
Phone
+98 21 8871 0099
Fax
Email
a-abbaszadeh@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Aliasghar Salahi kojoor
Position
Pastic Surgery Resident
Other areas of specialty/work
Street address
21st st. Yousefabad, Hazrat Fatemeh Hospital
City
Tehran
Postal code
Phone
+98 21 8871 0099
Fax
Email
a-abbaszadeh@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)