Protocol summary

Summary
This study is designed to evaluate the effect of fetal fibroblast on partial thickness wound healing. It is a double blind, randomized clinical trial which will be done on 10 patients who need skin graft surgery. Fetal fibroblast preparation: [Inclusion criteria are pregnant women, who are older than 18 years old and must have abortion, aborted fetus with age of 11 to 14 weeks, and filling out the informed consent. Exclusion criteria included pregnant women who are younger than 18 years old, aborted fetus younger than 11 weeks or older than 14 weeks, infectious diseases (HIV-HBV-HCV) and consumption of immune-suppressive drugs. After selecting the appropriate fetus, a 10×10 specimen of skin will be harvested and sent to Royan Institute for fibroblast isolation and culture. Clinical part of the trial has the following inclusion criteria: patients with age of 20 to 60 years old, those who need skin graft surgery, filling out the informed consent. Its exclusion criterion is co-morbidity. After harvesting skin graft, three 5×5 cm areas will be selected in lateral, anterior and medial parts of donor for examination. One of these areas will be randomly covered with acellular amnion loaded with fetal fibroblast; the second part will be covered with acellular amnion and the third one with Vaseline gauze. The surgeon who is dressing the wound is blind about type of the amnion. Speed of wound healing, pain, infection, scar and pathologic criteria of all the patients will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201302218177N6
Registration date: 2013-06-29, 1392/04/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-06-29, 1392/04/08
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
Royan Institute
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Acellular Amniotic membrane loaded by cultured fetal fibroblast cells in split thickness skin wound healing
Public title
The effects of fetal fibroblast in skin wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Laboratory inclusion criteria: 1. Pregnant women who are older than 18 years old that had to be aborted 2. Filling informed consent 3. Aborted fetus with the age of 11 to 14 weeks 4.Lack of infectious diseases (HIV-HBV-HCV) 5.Lack consumption of immune-suppressive and cytotoxic drugs during past 6 months Laboratory exclusion criteria: 1. Aborted fetus that is younger than 11 weeks or older than 14 weeks 2.Pregnant women who are younger than 18 years old Clinical inclusion criteria: 1.Patients with the age of 20 to 60 years old 2. Those who need skin graft surgery 3.The extent of surgical site wound 10-30% 4. Filling informed consent 5. Lack of co-morbidity Clinical exclusion criteria: 1.Under the age of 20 years and above 60 years 2.The extent of surgical site wound more than 30% and less than 10% 3.Lack of informed consent
Age
From 8 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Blvd, Tehran
City
Tehran
Postal code
1417653761
Approval date
2013-04-22, 1392/02/02
Ethics committee reference number
91-03-129-18724-80782

Health conditions studied

1

Description of health condition studied
Skin Wound
ICD-10 code
T14.1
ICD-10 code description
Open wound of unspecified body region

Primary outcomes

1

Description
Wound healing
Timepoint
Examination and photography on 3, 5, 7, 11, 13 and 15 days and 1 month after surgery - biopsy on 7 dayس after surgery
Method of measurement
Observation and Examination and Biopsy

Secondary outcomes

1

Description
Pain
Timepoint
Three, five, seven, nine, eleven, thirteen and fifteen days after surgery
Method of measurement
Visual Analogue Scale

2

Description
Infection
Timepoint
Seven and fifteen days after surgery
Method of measurement
Examination, Wound Culture

3

Description
Scar
Timepoint
Three and six months after surgery
Method of measurement
Vancouver Scar Scale

Intervention groups

1

Description
Intervention 1: Coverage of the skin graft donor site with acellular amnion loaded with cultured fetal fibroblast cell. The dressing will be changed every other day till complete healing of the wound after 3 days.
Category
Treatment - Other

2

Description
Intervention 2: Coverage of the skin graft donor site with acellular amnion. The dressing will be changed every other day till complete healing of the wound after 3 days.
Category
Treatment - Other

3

Description
Control group: Coverage of the skin graft donor site with Vaseline gauze. The dressing will be changed every other day till complete healing of the wound after 3 days.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahari Burn Hospital
Full name of responsible person
Mohammad Javad Fatemi
Street address
Shahid Motahari Burn Hospital, Rashid Yasami Ave, Vali Asr Ave, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical
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
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 Asadabadi Ave, Tehran
City
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Fax
Email
mj-fatemi@sina.tums.ac.ir
Web page address

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 Jamaleddin Asadabadi Ave, Tehran
City
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Fax
Email
mj-fatemi@sina.tums.ac.ir
Web page address

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
Email
mj-fatemi@sina.tums.ac.ir
Web page address

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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