Protocol summary

Study aim
the effectiveness of platelet gel derived from cord blood on the GVHD wound treatment.
Design
In this study, there are two groups (intervention and control) that are examined simultaneously is one patient and 15 patients are matched with children's medical center hospital. This intervention is the third phase of the trial. In this intervention, dressings are performed in three times for each patient which are changed on the other days.
Settings and conduct
The location of intervention is in the children 's medical center In this study blindness was not made and all patients and physicians are aware of the type and wound dressing structure.
Participants/Inclusion and exclusion criteria
The wound should be on the hand.The wound must be second degree ,Both of genders can be entered this study.The size of wound should be more than 5 cm2 and less than 10 cm2 ,exclusion criteria :The patients with other diseases such as diabetes, allergy and coagulopathy
Intervention groups
The intervention group consists of people who have wound of GVHD who meet the inclusion criteria mentioned above and receive the desired dressing (platelet gel derived from umbilical cord blood). The control group is also the same persons in the intervention group and receive routine treatment on the other wound caused by GVHD. The size of the wound caused by GVHD ,should be ​​more than 5 and less than10 cm*cm on the hand.
Main outcome variables
The effectiveness of platelet gel derived from cord blood on the GVHD wound treatment.

General information

Acronym
--
IRCT registration information
IRCT registration number: IRCT20141007019432N6
Registration date: 2018-04-27, 1397/02/07
Registration timing: registered_while_recruiting

Last update: 2018-04-27, 1397/02/07
Update count: 0
Registration date
2018-04-27, 1397/02/07
Registrant information
Name
Mohammadamir Amirkhani
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 1710
Email address
amirkhani@health.gov.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2018-03-11, 1396/12/20
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Application of Cord Blood Platelet Gel (CBPG) for treatment of skin ulcers due to cutaneous chronic GVHD
Public title
Application of Cord Blood Platelet Gel (CBPG) for treatment of skin ulcers due to cutaneous chronic GVHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The wound should be on the hand. The wound that have second degree Both of genders can be entered this study. The surface of wound should be more than 5 cm2 and less than 10cm2
Exclusion criteria:
The patients with other systemic diseases such as diabetes, allergy and coagulopathy
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
None
Sample size
Target sample size: 10
More than 1 sample in each individual
Number of samples in each individual: 2
Each person should have two areas of burn ulcer on his/her hands. one area will recieve the first intervention and the other one will recieve the second intervention
Actual sample size reached: 10
More than 1 sample in each individual
Actual sample size in each individual:
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 Tehran University Medical Sience
Street address
Tehran University of Medical Sciences, Cross Qods st, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Country
Iran (Islamic Republic of)
Postal code
1417653761
Approval date
2017-12-19, 1396/09/28
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4286

Health conditions studied

1

Description of health condition studied
Wound and GVHD
ICD-10 code
D89.81
ICD-10 code description
Graft-versus-host disease

Primary outcomes

1

Description
Formation of wound granulation tissue
Timepoint
before intervention and 6 days after last intervention
Method of measurement
Pictzar Software

2

Description
Reduction of wound area and depth
Timepoint
Before intervention and 6 day after the last intervention
Method of measurement
Surface and depth of the wound are examined by the pictzar software

Secondary outcomes

1

Description
wound pain
Timepoint
6 days after the first intervention
Method of measurement
Question and answer from the patient

2

Description
Timepoint
Method of measurement

Intervention groups

1

Description
Intervention group: in this study, 15 patients are selected from children's medical center hospital. The size of the wound caused by GVHD, should be more than 5 and less than 10 cm*cm ​​ on the hand. One of the wounds of GVHD is treated with new dressing (paletlet gel from the cord blood) and another wound of the same patient (on the hand) is treated with routine treatment at the same time. In this intervention, three dressings in three times are performed for each patient every other days.
Category
N/A

2

Description
Control group: At the same time, the same patients who have another wound on their hands receive dressing including routine treatment (in this group platelet gel derived from umbilical cord blood don't used).
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Skin & Stem Cell Research Center of Tehran University
Full name of responsible person
Mohammad Amir Amirkhani
Street address
Tehran -Iran Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Province
Tehran
Country
Iran (Islamic Republic of)
Postal code
1937957511
Phone
+98 21 2220 1710
Email
Amirkhani2000@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Skin & Stem Cell Research Center of Tehran Medical Science University
Full name of responsible person
Prof. Mohammadali Nilforoushzadeh
Street address
Street address Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Province
Tehran
Country
Iran (Islamic Republic of)
Postal code
1937957511
Phone
+98 21 2220 1710
Fax
+98 21 2220 1710
Email
dr_nilforoush@yahoo.com
Web page address
Grant name
Skin & Stem Cell Research Center of Tehran Medical Science University
Grant code / Reference number
Non grant code
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Skin & Stem Cell Research Center of Tehran Medical Science University
Proportion provided by this source
30
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
Skin & Stem Cell Research Center of Tehran Medical Science
Full name of responsible person
Mohammad Amir Amirkhani
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Skin& Stem Cell
Street address
Tehran -Iran Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Province
Tehran
Country
Iran (Islamic Republic of)
Postal code
1937957511
Phone
+98 21 2220 1710
Email
Amirkhani2000@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Amirali Hamidieh
Position
Associate professor،Stem Cell and Technology Development
Latest degree
Specialist
Other areas of specialty/work
Hematology and Oncology Stem Cell Transplantation
Street address
Gharib street children's Medical Center of Imam khomeiny Hospital Tehran Iran
City
Tehran
Province
Tehran
Country
Iran (Islamic Republic of)
Postal code
1937957511
Phone
+98 912 159 3270
Fax
Email
aahamidieh@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elham Torkamaniha
Position
Master of science in biotechnology
Latest degree
Master
Other areas of specialty/work
Skin& Stem Cell
Street address
Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Province
Tehran
Country
Iran (Islamic Republic of)
Postal code
1937957511
Phone
+98 21 2220 1710
Email
elham_torkamaniha@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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
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