Objective: Evaluation the effect of Plasma Rich Platelet gel on the rate of donor site wound healing in burn patients. Method: 35 patients with burns deep IIB and III will be chosen. In each case the removal of skin grafts for transplantation will be divided into two parts. In an area first PRP gel topically, then standard dressing will be used, but in another area just a standard dressing will be used. On the day of 10th and 30th, acceleration of macroscopic healing will be evaluated by two experts on wound epithelialization and granulation, pigmentation and surface vascularity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030716148N4
Registration date:2017-05-20, 1396/02/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-20, 1396/02/30
Registrant information
Name
Samira Foji
Name of organization / entity
Sabzevar University of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 57 1265 4874
Email address
foji.s1@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Sabzevar University of Medical Sciences
Expected recruitment start date
2015-07-07, 1394/04/16
Expected recruitment end date
2016-01-06, 1394/10/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Plasma Rich Platelet gel on the rate of donor site wound healing in burn patients :Triple-blind clinical trial.
Public title
Clinical trial of comparing the effects of platelet-rich plasma gel on wound healing harvesting grafts in burn patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 15 and 60 years of age؛ autologous skin grafts to repair burns require surgery؛ having informed consent and willingness to participate in the plan.
Exclusion criteria:
To continue to cooperate dissatisfied for any reason and at any stage of the research؛ lack of time set for review؛ an underlying disease such as connective tissue disease, diabetes, cancer, malnutrition, sepsis and .... ؛platelet 100000 or hemoglobin below 10 age younger than 15 and older than 60 years؛ infected or inflamed area harvested skin grafts from any cause؛ any manipulation on the wound harvest skin grafts؛ use of systemic corticosteroids 2 weeks ago؛ the use of nonprescription drugs or medication on the skin graft harvest؛ NSAID consumption up to 72 hours in advance؛ hemodynamic disorders.
Age
From 15 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar - Tawhid shahr - University of Medical Sciences
City
Sabzevar
Postal code
Approval date
2015-07-06, 1394/04/15
Ethics committee reference number
Ir.Medsb.Rec.1394.40
Health conditions studied
1
Description of health condition studied
burn
ICD-10 code
T30.2
ICD-10 code description
Burn of second degree, body region unspecified
2
Description of health condition studied
burn
ICD-10 code
T30.3
ICD-10 code description
Burn of third degree, body region unspecified
Primary outcomes
1
Description
The extent of epithelialization
Timepoint
Day 10
Method of measurement
Morphologhy
2
Description
The amount of granulation
Timepoint
Day 10
Method of measurement
Morphology
3
Description
The amount of pigmentation
Timepoint
Day 30
Method of measurement
Morphology
4
Description
The amount of surface vascularity
Timepoint
Day 30
Method of measurement
Morphology
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the use of platelet-rich plasma gel on skin graft harvest site and then using of standard dressing
Category
Treatment - Drugs
2
Description
Control group: the use of standard dressing on skin graft harvest site
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The burn unit of Vasei Hospital of Sabzevar
Full name of responsible person
Sajad Kazemi
Street address
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Sabzevar University of Medical Sciences
Full name of responsible person
Dr Mohamad Mohamadsadeh
Street address
Tawhid Shahr, Pardis University of Medical Sciences
City
Sabzevar
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 Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Sajad Kazemi
Position
Medical Student
Other areas of specialty/work
Street address
Tawhid Shahr, Pardis University of Medical Sciences
City
Sabzevar
Postal code
Phone
+98 45 3245 1793
Fax
Email
sajad_1370@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Sajad Kazemi
Position
Medical Student
Other areas of specialty/work
Street address
Tawhid Shahr, Pardis University of Medical Sciences
City
Sabzevar
Postal code
Phone
+98 453251793
Fax
Email
sajad_1370@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Sajad Kazemi
Position
Medical Student
Other areas of specialty/work
Street address
Tawhid Shahr, Pardis University of Medical Sciences
City
Sabzevar
Postal code
Phone
+98 453251793
Fax
Email
sajad_1370@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)