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

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.

Study Overview

• Status: Unknown
• Conditions: Sternal Wound Repair
• Intervention / Treatment: Biological: PRF; Biological: placebo group

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • East Azarbyjan
    • Tabriz, East Azarbyjan, Iran, Islamic Republic of, 0413
      • Recruiting
      • SCARM
      • Contact: Sepideh jalilzade, MSc; Phone Number: 04133349525
      • Sub-Investigator: Sepideh Jalilzadeh, Msc
      • Sub-Investigator: Yousef Faridvand, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PRF group; patients who will receive Platelet Rich Fibrin (PFR) suspension	Biological: PRF; patients who will receive PRF suspension
EXPERIMENTAL: placebo group	Biological: placebo group; patients who will receive Placebo

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

Collaborators and Investigators

• Sponsor: SCARM Institute, Tabriz, Iran
• Investigators: Study Director: Ahmad Reza Jodati, CTS, SCARM Institute

Publications and helpful links

General Publications

• Tashnizi MA, Alamdari DH, Khayami ME, Rahimi HR, Moeinipour A, Amouzeshi A, Seifalian AM. Treatment of non-healing sternum wound after open-heart surgery with allogenic platelet-rich plasma and fibrin glue-preliminary outcomes. Indian J Plast Surg. 2013 Sep;46(3):538-42. doi: 10.4103/0970-0358.122011.
• Serraino GF, Dominijanni A, Jiritano F, Rossi M, Cuda A, Caroleo S, Brescia A, Renzulli A. Platelet-rich plasma inside the sternotomy wound reduces the incidence of sternal wound infections. Int Wound J. 2015 Jun;12(3):260-4. doi: 10.1111/iwj.12087. Epub 2013 May 21.
• Cotogni P, Barbero C, Rinaldi M. Deep sternal wound infection after cardiac surgery: Evidences and controversies. World J Crit Care Med. 2015 Nov 4;4(4):265-73. doi: 10.5492/wjccm.v4.i4.265. eCollection 2015 Nov 4.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 5, 2020
• Primary Completion (ANTICIPATED): October 15, 2020
• Study Completion (ANTICIPATED): December 25, 2020

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: June 9, 2017
• First Posted (ACTUAL): June 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: SCARM-Sternum repair

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No