The effect of Plasma Rich Plasma(PRP) fortified with vitamin C on wound healing and pain relief can be useful in achieving better therapeutic effects and reducing the healing time and complications of skin grafting, especially among burn patients.
Design
A clinical trial with a control group,with parallel groups,a blind strain,was used on 30 patients.
Settings and conduct
Hospital .Burn section.
After collecting complete information from the study, the two groups under study are coded with the names A and B. In such a way that the data analyst does not know the treatment method and after the data analysis, the treatment methods will replace the letters.
Participants/Inclusion and exclusion criteria
All burn hospitals that require skin grafts are included in the study.
Patients with underlying disease and addiction are excluded from the study.
Intervention groups
All burn hospitals that require skin grafts are included in the study.
Patients with underlying disease and addiction are excluded from the study.
Main outcome variables
Age, Gender, Pain, Appearance, Pathology.'
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220620055224N1
Registration date:2022-07-13, 1401/04/22
Registration timing:prospective
Last update:2022-07-13, 1401/04/22
Update count:0
Registration date
2022-07-13, 1401/04/22
Registrant information
Name
alireza narimani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3623 0866
Email address
alirezanarimani7799@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of PRP (Platelet-Rich Plasma) enriched with vitamin C on skin graft site in burn patients
Public title
The effect of prp enriched with vitamin C on the skin donor site
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Burn patients need a graft
Exclusion criteria:
Addiction
Underlying disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
In each patient after graft removal at the end of the operation, the dressing method of the two sides is different.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not 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 Kerman University of Medical Sciences
Street address
Bahonar hospital, Gharani St, Kerman Town.
City
Kerman
Province
Kerman
Postal code
7613747181
Approval date
2022-04-10, 1401/01/21
Ethics committee reference number
IR.KMU.AH.REC.1401.010
Health conditions studied
1
Description of health condition studied
Burn patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Assessing pain using a pain scale.
Timepoint
The amount of pain on a daily basis for up to 5 days.
Method of measurement
Patient pain rate using Visual analog scale(VAS)
2
Description
Examining the pathology of the donnor graft site.
Timepoint
Pathology examination on the fifth day after graft removal.
Method of measurement
microscope.
Secondary outcomes
1
Description
Evaluation of patients' pain based on visual analog scale(VAS)
Timepoint
Daily
Method of measurement
Visual analouge scale
Intervention groups
1
Description
Intervention group: 20 cc of the patient's blood is taken and its plasma is separated by a centrifuge and mixed with vitamin C at a concentration of 15% and sprayed daily for 5 days at the donnor graft site.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences.
Proportion provided by this source
100
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
Kerman University of Medical Sciences
Full name of responsible person
Dr. Seyed Hasan Hosseini Hushyar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Bahonar Hospital, Gharani st, Kerman Town.
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
bahonarhospital@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Seyed Hasan Hosseini Hushyar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Bahonar Hospital, Gharani st, Kerman Town.
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
bahonarhospital@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Seyed Hasan Hosseini Hushyar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Bahonar Hospital, Gharani st, Kerman Town.
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
bahonarhospital@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After preserving the personal information of the patients, all the information collected from the patients will be available after observing the ethical principles.
When the data will become available and for how long
After gathering information and completing the study
To whom data/document is available
All university centers
Under which criteria data/document could be used
Based on ethical principles and the opinion of the ethics committee
From where data/document is obtainable
Ethics committee
What processes are involved for a request to access data/document