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Status unknownNCT03183973Updated Oct 27, 2020

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

A Phase 1/2 interventional study of PRF and placebo group in Sternal Wound Repair, sponsored by SCARM Institute, Tabriz, Iran. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-10-27.

Sponsored by SCARM Institute, Tabriz, Iran · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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Conditions studied

  • Sternal Wound Repair

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03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    PRF group

    patients who will receive Platelet Rich Fibrin (PFR) suspension

    Biological: PRF

  • Experimental
    placebo group

    Biological: placebo group

Interventions

  • BiologicalPRF

    patients who will receive PRF suspension

  • Biologicalplacebo group

    patients who will receive Placebo

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What researchers measure

Primary outcomes

  1. Scar formation

    Appearance of operative scar diagnose by cardiothoracic surgeon

    Time frame: post operative- until release from hospitalization up to 1 month

  2. Wound Infection

    wound infection incidence diagnose by cardiothoracic surgeon

    Time frame: post operative- until release from hospitalization up to 1 month

  3. Bruising

    Average Bruise Change diagnose by cardiothoracic surgeon

    Time frame: post operative- until release from hospitalization up to 1 month

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Study locations

1 of 1 sites recruiting
  • SCARM
    Tabriz, East Azarbyjan 0413, Iran, Islamic Republic of
    • Sepideh jalilzade, MSc · Contact · 04133349525
    • Sepideh Jalilzadeh, Msc · Sub investigator
    • Yousef Faridvand, Ph.D · Sub investigator
    Recruiting
07

References and documents

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. PubMed 24459346 ↗
  • 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. PubMed 23692143 ↗
  • 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. PubMed 26557476 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03183973
Lead sponsor
SCARM Institute, Tabriz, Iran
Responsible party
Sponsor
First posted
Jun 12, 2017
Start date
Mar 5, 2020
Primary completion
Oct 15, 2020 (estimated)
Completion
Dec 25, 2020 (estimated)
Last update
Oct 27, 2020

Study contacts

Ahmad Reza Jodati, CTS
Contact
Jodatia@yahoo.com
0413 33349525
Peyman Keyhanvar
Contact
drkeyhanvar@gmail.com
0914 114 6863
Mohammad Nouri, Ph.D
study chair · Head of SCARM Institute
Ahmad Reza Jodati, CTS
study director · SCARM institute
Peyman Keyhanvar, MD, Ph.D
principal investigator · Deputy for translational medicine of SCARM institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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