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

Phase 1

• Conditions: Sternal Wound Repair
• Interventions: Biological: PRF; Biological: placebo group

• Registration Number: NCT03183973
• Lead Sponsor: SCARM Institute, Tabriz, Iran

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-09
• Study First Posted: 2017-06-12
• Study Start: 2020-03-05
• Status Verified: 2020-06
• Primary Completion: 2020-10-15
• Last Update Submitted: 2020-10-24
• Last Update Posted: 2020-10-27
• Study Completion: 2020-12-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRF group	PRF	patients who will receive Platelet Rich Fibrin (PFR) suspension
placebo group	placebo group	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

SCARM; 🇮🇷 Tabriz, East Azarbyjan, Iran, Islamic Republic of