Protocol summary
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Study aim
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the effectiveness of platelet gel derived from cord blood on the GVHD wound treatment.
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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The effectiveness of platelet gel derived from cord blood on the GVHD wound treatment.
General information
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Reason for update
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Acronym
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--
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IRCT registration information
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IRCT registration number:
IRCT20141007019432N6
Registration date:
2018-04-27, 1397/02/07
Registration timing:
registered_while_recruiting
Last update:
2019-02-14, 1397/11/25
Update count:
1
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Registration date
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2018-04-27, 1397/02/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-03-11, 1396/12/20
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Expected recruitment end date
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2019-03-11, 1397/12/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Application of Cord Blood Platelet Gel (CBPG) for treatment of skin ulcers due to cutaneous chronic GVHD
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Public title
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Application of Cord Blood Platelet Gel (CBPG) for treatment of skin ulcers due to cutaneous chronic GVHD
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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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:
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-12-19, 1396/09/28
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Ethics committee reference number
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IR.TUMS.VCR.REC.1396.4286
Health conditions studied
1
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Description of health condition studied
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Wound and GVHD
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ICD-10 code
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D89.81
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ICD-10 code description
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Graft-versus-host disease
Primary outcomes
1
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Description
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Formation of wound granulation tissue
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Timepoint
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before intervention and 6 days after last intervention
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Method of measurement
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Pictzar Software
2
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Description
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Reduction of wound area and depth
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Timepoint
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Before intervention and 6 day after the last intervention
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Method of measurement
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Surface and depth of the wound are examined by the pictzar software
Secondary outcomes
1
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Description
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wound pain
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Timepoint
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6 days after the first intervention
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Method of measurement
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Question and answer from the patient
Intervention groups
1
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Description
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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.
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Category
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N/A
2
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Description
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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).
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Category
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N/A
1
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Sponsor
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Grant name
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Skin & Stem Cell Research Center of Tehran Medical Science University
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Grant code / Reference number
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Non grant code
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Skin & Stem Cell Research Center of Tehran Medical Science University
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Proportion provided by this source
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30
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available