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IRCT20170221032714N4 IRCT 2018-03-29 Tabriz University of Medical Sciences Applicability of Platelet Rich Fibrin (PRF) in closure of non-healing Sternum wound Study of the effect of Platelet Rich Fibrin (PRF) in closure of non-healing Sternum wound after open-heart Surgery 2018-04-04 anticipated 10 Complete https://irct.ir/trial/29939 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will take place in base on a restricted, block randomization, 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. 2-3 Sternal Wound Repair. Intervention 1: Intervention group: Platelet Rich Fibrin (PFR) group. Intervention 2: Control group: placebo group. Yes - There is a plan to make this available What will be shared: Share with other studies and collaborate with other research and clinical centers to increase the effectiveness of the study When: After the study is completed and 6 months after the results are printed To whom: Research Centers and Study Groups of Basic Sciences and Clinical Sciences Conditions: It is possible to use the analyzed results after receiving written permission from the executor Where to obtain: Principal Investigator or corresponding author of study How to obtain: After a written request for the use of results in clinical studies Comments:
public Ahmad Reza Jodati
University st., Madani hospital
Tabriz Iran (Islamic Republic of) 98413 +98 41333349525 Jodati@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Ahmad Reza Jodati
University st., Madani hospital
Tabriz Iran (Islamic Republic of) 98413 +98 41333349525 Jodati@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 65 years Both 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. S22.23XG Sternal manubrial dissociation, subsequent encounter for fracture with delayed healing Treatment - Surgery Placebo Intervention group: Platelet Rich Fibrin (PFR) group Control group: placebo group 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. 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. NCT03183973 Clinical trials.gov Tabriz University of Medical Sciences Approved 2017-10-02 Ethics committee of Tabriz University of Medical Sciences University street., tabriz., Iran Tabriz East Azarbaijan Iran (Islamic Republic of)