Assessment the effect of using autologous platelet rich plasma (PRP) in prevention of hypertrophic scar at the site of sternotomy in children with open heart surgery
Determining the effectiveness of autologous platelet rich plasma in prevention of hypertrophic scar at the site of sternotomy in children with open heart surgery
Design
Participants in this study are the children who undergo open heart surgery in Shahid Modarres Hospital.Each patient on this trial will be considered as his control.This study counts as a single-blinded study so that the evaluator of the hypertrophic scar's site doesn't know the location of the PRP injection.Based on similar articles, the sample size was measured 50 people.For sampling, the people who have the inclusion criteria enroll in the study,after signing the informed consent.
Settings and conduct
The children who undergo open heart surgery in Shahid Modarres hospital and have the inclusion criteria will enroll in the study.Their wound at the site of midsternotomy is divided into two parts.Then, 0.1 cc of prp per 1cm of wound is injected randomly in one part and normal saline as placebo in the other part.The wound site will be assessed at 2nd,12th and 24th weeks after surgery by a trained personnel who don't know location of prp injection
Participants/Inclusion and exclusion criteria
Not having diabetes,autoimmune disease and thrombocytopenia;Not receiving glucocorticoids
Intervention groups
Certain amount of blood in accordance with patient wound length is taken from patient via scalp vein,before using anesthetics and anti coagulants .PRP is prepared by an educated person with the help of centrifuge .The midsternal wound is divided into two parts. PRP is injected into lower half and normal saline solution in the other half as a placebo.Thus every patient is considered as control too. The scar at sternum will be evaluated at 2nd, 12th and 24th weeks after the surgery by an educated person not aware of the site of the PRP injection.
Main outcome variables
Hypertrophic scar score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201007048955N2
Registration date:2020-10-31, 1399/08/10
Registration timing:prospective
Last update:2020-10-31, 1399/08/10
Update count:0
Registration date
2020-10-31, 1399/08/10
Registrant information
Name
zahra ansari aval
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2208 3095
Email address
z.ansari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of using autologous platelet rich plasma (PRP) in prevention of hypertrophic scar at the site of sternotomy in children with open heart surgery
Public title
Assessment the effect of using autologous platelet rich plasma (PRP) in prevention of hypertrophic scar
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Not having diabetes
Not having autoimmune disease
Not having thrombocytopenia(platelets below 150000)
Not receiving glucocorticoids
Exclusion criteria:
Patient not referring to the doctor for surveillance
Death of the patient during the surveillance period
Age
To 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients' wound at the site of mid-sternotomy is divided into upper and lower parts, then 0.1 cc of PRP per 1 cm of wound length is injected in lower part and 0.1 cc of normal saline per 1 cm of wound length as placebo in the other part. Patients' wounds are then assessed at 2nd, 12th and 24th weeks after surgery by another person who does not know the injection site of PRP and placebo , and the hypertrophic scars in both areas is evaluated by using the Vancouver scar scale(VSS).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shaheed Beheshti University of Medical Sciences and Health Services, Beside Taleghani Hospital,Tabnak St. , Evin, Shaheed Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-02-26, 1397/12/07
Ethics committee reference number
IR.SBMU.MSP.REC.1397.783
Health conditions studied
1
Description of health condition studied
Hypertrophic scar
ICD-10 code
L91.0
ICD-10 code description
Hypertrophic scar
Primary outcomes
1
Description
Hypertrophic scar score
Timepoint
2nd, 12th and 24th weeks after surgery
Method of measurement
Based on Vancouver scar scale(VSS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Before the induction of surgery and injection of anesthetics and anticoagulants, a certain volume of blood in accordance with patient wound length is taken from the patient .PRP is prepared by an educated person with the help of a centrifuge . The midsternal wound is divided into two parts. PRP is injected into lower half and normal saline solution in the other half as a placebo. Thus every patient himself is considered as control too. The scar formed at the wound site will be assessed at 2nd, 12th and 24th weeks after the surgery by an educated person not aware of the site of the PRP injection.
Category
Prevention
2
Description
Control group:Before the induction of surgery and injection of anesthetics and anticoagulants, a certain volume of blood in accordance with patient wound length is taken from the patient .PRP is prepared by an educated person with the help of a centrifuge . The midsternal wound is divided into two parts.Normal saline is injected into Upper half and PRP solution in the other half.Thus every patient himself is considered as control too. The scar formed at the wound site will be assessed at 2nd, 12th and 24th weeks after the surgery by an educated person not aware of the site of the PRP injection.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarress Educational Hospital
Full name of responsible person
Pouya Pourahmad Kisomi
Street address
Shahid Modarress Educational Hospital, Saadat Abad St. Yadegare Imam Highway
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
modarres@sbmu.ac.ir
Web page address
http://modarres.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Clinical Research Development Center
Full name of responsible person
Naser Malekpour
Street address
Saadatabad intersection, Yadegar Imam Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
Nassermalekpour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Clinical Research Development Center
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pouya Pourahmad
Position
Student of Medical sciences
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No 5 , west ghobadiyan Ave ,Alborz St,Mirdamad blv
City
Tehran
Province
Tehran
Postal code
1918944681
Phone
0098 26410223
Email
bvbppk@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Ansari aval
Position
Deputy Director in education, Research shahid modarres medical center
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shahid Modarres Hospital, Above Kaj Square, Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2208 3095
Email
z.ansari@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pouya Pourahmad kisomi
Position
Student of Medical sciences
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No 5 , west ghobadiyan Ave ,Alborz St,Mirdamad blv
City
Tehran
Province
Tehran
Postal code
1918944681
Phone
0098 26410223
Email
bvbppk@gmail.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
In order to protect the patients' personal information, the participants' data cannot be revealed.
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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available