Sternal Wound Repair
Conditions
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.
Interventions
BIOLOGICALPRF
patients who will receive PRF suspension
BIOLOGICALplacebo group
patients who will receive Placebo
Sponsors
SCARM Institute, Tabriz, Iran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scar formation | post operative- until release from hospitalization up to 1 month | Appearance of operative scar diagnose by cardiothoracic surgeon |
| Wound Infection | post operative- until release from hospitalization up to 1 month | wound infection incidence diagnose by cardiothoracic surgeon |
| Bruising | post operative- until release from hospitalization up to 1 month | Average Bruise Change diagnose by cardiothoracic surgeon |
Countries
Iran
Contacts
Primary ContactAhmad Reza Jodati, CTS
Backup ContactPeyman Keyhanvar
Outcome results
None listed