Effects of Platelet Rich Fibrin (PRF) in Treatment of Non-healing Sternum Wound After Open-heart Surgery

Study Overview
=================
Brief Summary
-----------------
Sternal wound and there complication such as infection, Bruising and scar formation are known as major complication cardiac surgery with a high mortality rate up to 50%. Several approaches have been proposed for treatment of chronic sternal wounds in these patients. however, Underlying confounding factors such as old ages,diabetes mellitus, systemic hypoxia, atherosclerosis and malnutrition have main role against wound repairing. In this study investigators aimed to treatment of patients with open heart surgery and need to strict monitoring of sternal wound repair by Platelet Rich Fibrin.

Official Title
-----------------
Effects of Platelet Rich Fibrin (PRF) in Treatment of Non-healing Sternum Wound After Open-heart Surgery

Conditions
-----------------
Sternal Wound Repair

Intervention / Treatment
-----------------
* Biological: PRF
* Biological: placebo group


Participation Criteria
=================
Eligibility 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 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 postsurgical 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRF group<br>patients who will receive Platelet Rich Fibrin (PFR) suspension | Biological: PRF<br>* patients who will receive PRF suspension<br>|
| Experimental: placebo group<br> | Biological: placebo group<br>* patients who will receive Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar formation | Appearance of operative scar diagnose by cardiothoracic surgeon | post operative- until release from hospitalization up to 1 month | 
| Wound Infection | wound infection incidence diagnose by cardiothoracic surgeon | post operative- until release from hospitalization up to 1 month | 
| Bruising | Average Bruise Change diagnose by cardiothoracic surgeon | post operative- until release from hospitalization up to 1 month |