Study of the effect of Platelet Rich Fibrin (PRF) in closure of non-healing Sternum wound after open-heart Surgery
Design
Clinical trial has been designed with control group, treatment group, with parallel groups, blind, randomized
Settings and conduct
The patients will be referred to the Shahid Madani Hospital who have undergone bypass surgeries and will be divided into two groups, after satisfaction, who will receive randomized, double-blind, platelet-rich fibrin therapy.
Participants/Inclusion and exclusion criteria
Inclusion criteria:The patient has been diagnosed with an acute STEMI or NSTEMI; The patient is scheduled to undergo coronary artery bypass surgery; The patient does not possess any contraindication for cardiovascular magnetic resonance (CMR); The patient is capable of giving informed consent; The patient is geographically accessible and willing to return for all follow-up investigations and clinical visits associated with study.
Exclusion criteria:The patient has previous myocardial infarction (MI) and/or has scar or non-viable myocardium identified; The patient is undergoing other cardiac surgery; The patient requires emergency surgery within 24-hrs of assessment; The patient has undergone previous cardiac surgery
Intervention groups
Patients experimental group: who will receive Platelet Rich Fibrin (PFR) suspension with standard medical therapy
placebo experimental group: who will receive standard medical therapy
Main outcome variables
the effect of Platelet Rich Fibrin (PRF) in closure of sternum wound
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170221032714N4
Registration date:2018-03-29, 1397/01/09
Registration timing:prospective
Last update:2018-03-29, 1397/01/09
Update count:0
Registration date
2018-03-29, 1397/01/09
Registrant information
Name
Peyman Keyhanvar
Name of organization / entity
Stem Cell and Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 914 114 6863
Email address
keyhanvarp@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2019-04-06, 1398/01/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of Platelet Rich Fibrin (PRF) in closure of non-healing Sternum wound after open-heart Surgery
Public title
Applicability of Platelet Rich Fibrin (PRF) in closure of non-healing Sternum wound
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has been diagnosed with an acute STEMI or NSTEMI (confirmed by segment elevation (ST) changes on serial ECG, elevated troponin, coronary artery stenosis or occlusion identified by angiography, and a wall motion abnormality identified by angiography or echocardiography); The patient is scheduled to undergo coronary artery bypass surgery;The patient does not possess any contraindication for cardiovascular magnetic resonance (CMR); The patient is capable of giving informed consent; The patient is geographically accessible and willing to return for all follow-up investigations and clinical visits associated with study.
Exclusion criteria:
The Exclusion criteria of study: The patient is over the age of 65 years; The patient has previous myocardial infarction (MI) (other than the qualifying event) and/or has scar or non-viable myocardium identified by CMR in any other left ventricular (LV) territory; The patient is undergoing other cardiac surgery (i.e. concurrent cardiac valve, or aortic surgery); The patient requires emergency surgery (i.e. operative intervention (CABG or ventricular assist device) within 24-hrs of assessment); The patient has undergone previous cardiac surgery; The patient's post-surgical life expectancy is less than 45 days, in the investigator's opinion; The patient is of excessively poor baseline health, health-related quality of life, or physical functioning that would preclude a reasonable expected post-operative recovery; The patient has received radiotherapy to the chest wall, is receiving immunosuppressive therapy, or is in any way immunocompromised.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will take place in base on a restricted, block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Blind groups will include participating and research groups. In case of blindness, based on a doctor's request, a placebo and active treatment will be given to the nurse to be used by the physician. all patients are aware of the standard treatment except active treatment group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Clinical trials.gov
Secondary trial Id
NCT03183973
Registration date
2017-07-01, 1396/04/10
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
University street., tabriz., Iran
City
Tabriz
Province
East Azarbaijan
Postal code
98413
Approval date
2017-10-02, 1396/07/10
Ethics committee reference number
IR.TBZMED.REC.1396.591
Health conditions studied
1
Description of health condition studied
Sternal Wound Repair
ICD-10 code
S22.23XG
ICD-10 code description
Sternal manubrial dissociation, subsequent encounter for fracture with delayed healing
Primary outcomes
1
Description
The bone formation in sternum
Timepoint
post operative- until release from hospitalization up to 1 month
Method of measurement
Cardiothoracic surgeon by assessment of photos which are taken from wound site
Secondary outcomes
1
Description
Scar formation or wound infection
Timepoint
post operative- until release from hospitalization up to 1 month
Method of measurement
by cardiothoracic surgeon and sample bacterial culture
Intervention groups
1
Description
Intervention group: Platelet Rich Fibrin (PFR) group
Category
Treatment - Surgery
2
Description
Control group: placebo group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani hospital; SCARM
Full name of responsible person
Peyman keyhanvar
Street address
university Street., Shahid Madani hospital
City
Tabriz
Province
East Azarbaijan
Postal code
98413
Phone
+98 41 3334 9525
Email
drkeyhanvar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ahmad Reza Jodati
Street address
University St.,
City
Tabriz
Province
East Azarbaijan
Postal code
98413
Phone
+98 41 3334 9525
Fax
Email
drkeyhanvar@gmail.com
Web page address
http://scarm.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ahmad Reza Jodati
Position
associated professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
University st., Madani hospital
City
Tabriz
Province
East Azarbaijan
Postal code
98413
Phone
+98 41333349525
Email
Jodati@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ahmad Reza Jodati
Position
associated professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
University st., Madani hospital
City
Tabriz
Province
East Azarbaijan
Postal code
98413
Phone
+98 41333349525
Email
Jodati@tbzmed.ac.ir
Web page address
http://scarm.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Peyman Keyhanvar
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Nanotechnology
Street address
University st., Madani Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
98413
Phone
+98 41333349525
Email
drkeyhanvar@gmail.com
Web page address
http://scarm.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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Share with other studies and collaborate with other research and clinical centers to increase the effectiveness of the study
When the data will become available and for how long
After the study is completed and 6 months after the results are printed
To whom data/document is available
Research Centers and Study Groups of Basic Sciences and Clinical Sciences
Under which criteria data/document could be used
It is possible to use the analyzed results after receiving written permission from the executor
From where data/document is obtainable
Principal Investigator or corresponding author of study
What processes are involved for a request to access data/document
After a written request for the use of results in clinical studies