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

NCT ID: NCT03183973

Last Updated: 2020-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-05

Study Completion Date

2020-12-25

Brief Summary

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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

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Conditions

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Sternal Wound Repair

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PRF group

patients who will receive Platelet Rich Fibrin (PFR) suspension

Group Type EXPERIMENTAL

PRF

Intervention Type BIOLOGICAL

patients who will receive PRF suspension

placebo group

Group Type EXPERIMENTAL

placebo group

Intervention Type BIOLOGICAL

patients who will receive Placebo

Interventions

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PRF

patients who will receive PRF suspension

Intervention Type BIOLOGICAL

placebo group

patients who will receive Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SCARM Institute, Tabriz, Iran

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohammad Nouri, Ph.D

Role: STUDY_CHAIR

Head of SCARM Institute

Ahmad Reza Jodati, CTS

Role: STUDY_DIRECTOR

SCARM institute

Peyman Keyhanvar, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Deputy for translational medicine of SCARM institute

Locations

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SCARM

Tabriz, East Azarbyjan, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Ahmad Reza Jodati, CTS

Role: CONTACT

[email protected]
0413 33349525

Peyman Keyhanvar

Role: CONTACT

[email protected]
0914 114 6863

Facility Contacts

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Sepideh jalilzade, MSc

Role: primary

04133349525

References

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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.

Reference Type RESULT
PMID: 24459346 (View on PubMed)

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.

Reference Type RESULT
PMID: 23692143 (View on PubMed)

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.

Reference Type RESULT
PMID: 26557476 (View on PubMed)

Other Identifiers

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SCARM-Sternum repair

Identifier Type: -

Identifier Source: org_study_id