Protocol summary

Summary
This study is designed to evaluate effects of stem cells on healing skin graft donor sites and third degree burn wounds. It is a randomized, clinical trial, which will be done on 20 patients (10 skin graft and 10 burn patients). These patients' inclusion criteria include: age of 18 – 60 years old, who require skin graft surgery, or those who have third degree burn of less than 10% of TBSA. Exclusion criteria include: having co-morbidity. In all the patients, 30 ml of fat will be suctioned from the abdominal area under local anesthesia. Its stem cells will be then separated and cultured. Cell characteristics will be determined after appropriate passage. Afterwards, these stem cells will be transferred to amnion, which become acellular enzymatically. The skin graft donor wound in thigh will be divided to medial, lateral and middle parts. Then, each part will be randomly covered by 1- acellular amnion loaded with stem cell, 2- acellular amnion and 3- Vaseline gauze. In the second group of patients, burning scar will be removed during the surgery. Wound site will be divided to three parts and covered in a similar fashion to the first group. Healing speed of the wounds, characteristics of scar and histopathology criteria will be compared with each other.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201209178177N5
Registration date: 2013-06-12, 1392/03/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-06-12, 1392/03/22
Registrant information
Name
Mohammad Javad Fatemi
Name of organization / entity
Burn Research Center of Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 4275
Email address
mj-fatemi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bonyakhte Institute
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2017-03-15, 1395/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of amniotic membrane loaded with adipose-derived stem cells on skin graft donor site and 3rd degree burn wound healing
Public title
Effect of amniotic membrane loaded with adipose-derived stem cells on skin graft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. Eighteen to sixty years old patients 2. Needing skin graft surgery or with 3rd degree burn less than 10% of TBSA 3. signing informed consent Exclusion criteria: Co-morbidity
Age
From 18 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 20
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

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central Department of Tehran University of Medical Sciences, Keshavarz Bvld, Tehran
City
Tehran
Postal code
1417653761
Approval date
2013-04-22, 1392/02/02
Ethics committee reference number
90-01-129-13379-80780

Health conditions studied

1

Description of health condition studied
Burn
ICD-10 code
T20, T21,
ICD-10 code description
Burns and corrosions of external body surface, specified by site

Primary outcomes

1

Description
Wound healing
Timepoint
Every other day after surgery
Method of measurement
Observation, Examination, Photography

2

Description
Epithelization
Timepoint
One month after surgery
Method of measurement
Observation, Examination, Photography, Biopsy

Secondary outcomes

1

Description
Infection
Timepoint
5 days after surgery
Method of measurement
Wound Culture

2

Description
Scar
Timepoint
Six months and one year after surgery
Method of measurement
Vancouver Scar Scale

Intervention groups

1

Description
Intervention 1: Coverage of the skin graft donor site or burn wound with acellular amnion loaded with fat derived-stem cell. The dressing will be changed after 5 days and then every other day till complete healing of the wound.
Category
Treatment - Other

2

Description
Intervention 2: Coverage of skin graft donor site or burn wound with acellular amnion. The dressing will be changed after 5 days and then every other day till complete healing of the wound.
Category
Treatment - Other

3

Description
Control group: Coverage of skin graft donor site or burn wound with Vaseline gauze. The dressing will be changed after 5 days and then every other day till the complete healing of the wound.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Fatima Hospital
Full name of responsible person
Mohammad Javad Fatemi
Street address
Hazrat Fatima Hospital, Seyed Jamaleddin Asadabadi Ave, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Central Department of Tehran University of Medical Sciences, Keshavarz Bvld, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of 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
Hazrat Fatima Hospital
Full name of responsible person
Mohammad Javad Fatemi
Position
Associate Professor of Plastic and Reconstructive Surgery
Other areas of specialty/work
Street address
Hazrat Fatima Hospital, Seyed Jamaleddin Assadabadi Ave, Tehran
City
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Fax
+98 21 8872 3150
Email
mj-fatemi@sins.tums.ac.ir
Web page address
http://medicine.tums.ac.ir/default.aspx?p=730

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hazrat Fatima Hospital
Full name of responsible person
Mohammad Javad Fatemi
Position
Associate Professor of Plastic and Reconstructive Surgery
Other areas of specialty/work
Street address
Hazrat Fatima Hospital, Seyed Jamleddin AsadAabadi Ave, Tehran
City
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Fax
+98 21 8872 3150
Email
mj-fatemi@sina.tums.ac.ir
Web page address
http://medicine.tums.ac.ir/default.aspx?p=730

Person responsible for updating data

Contact
Name of organization / entity
Hazrat Fatima Hospital
Full name of responsible person
Mohammad Javad Fatemi
Position
Associate professor of Plastic and Reconstructive Surgery
Other areas of specialty/work
Street address
Hazrat Fatima Hospital, Seyed Jamaleddin Asadabadi Ave, Tehran
City
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Fax
+98 21 8872 3150
Email
mj-fatemi@sina.tums.ac.ir
Web page address
http://medicine.tums.ac.ir/default.aspx?p=730

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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