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

NCT03183973 | Unknown Phase 1 DMC

• 1 other identifier: SCARM-Sternum repair
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Sternal Wound Repair

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

PRF group

EXPERIMENTAL

patients who will receive Platelet Rich Fibrin (PFR) suspension

Biological: PRF

placebo group

EXPERIMENTAL

Biological: placebo group

Interventions

PRF BIOLOGICAL

patients who will receive PRF suspension

PRF group

placebo group BIOLOGICAL

patients who will receive Placebo

placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SCARM Institute, Tabriz, Iran: lead

Study Sites (1)

SCARM

Tabriz, East Azarbyjan, 0413, Iran

RECRUITING

Related Publications (3)

• 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.

  PMID: 24459346 RESULT

• 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.

  PMID: 23692143 RESULT

• 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.

  PMID: 26557476 RESULT

Study Officials

• Mohammad Nouri, Ph.D

  Head of SCARM Institute

  STUDY CHAIR

• Ahmad Reza Jodati, CTS

  SCARM institute

  STUDY DIRECTOR

• Peyman Keyhanvar, MD, Ph.D

  Deputy for translational medicine of SCARM institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmad Reza Jodati, CTS

CONTACT

0413 33349525; Jodatia@yahoo.com

Peyman Keyhanvar

CONTACT

0914 114 6863; drkeyhanvar@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 12, 2017
• Study Start: March 5, 2020
• Primary Completion: October 15, 2020
• Study Completion: December 25, 2020
• Last Updated: October 27, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)