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

Primary Purpose

Sternal Wound Repair

Status

Unknown status

Phase

Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

PRF

placebo group

About this trial

This is an interventional treatment trial for Sternal Wound Repair

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

SCARMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

PRF group

placebo group

Arm Description

patients who will receive Platelet Rich Fibrin (PFR) suspension

Outcomes

Primary Outcome Measures

Scar formation

Appearance of operative scar diagnose by cardiothoracic surgeon

Wound Infection

wound infection incidence diagnose by cardiothoracic surgeon

Bruising

Average Bruise Change diagnose by cardiothoracic surgeon

Secondary Outcome Measures

Full Information

NCT ID

NCT03183973

First Posted

May 31, 2017

Last Updated

October 24, 2020

Sponsor

SCARM Institute, Tabriz, Iran

1. Study Identification

Unique Protocol Identification Number

NCT03183973

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Unknown status

Study Start Date

March 5, 2020 (Actual)

Primary Completion Date

October 15, 2020 (Anticipated)

Study Completion Date

December 25, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SCARM Institute, Tabriz, Iran

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sternal Wound Repair

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PRF group

Arm Type

Experimental

Arm Description

patients who will receive Platelet Rich Fibrin (PFR) suspension

Arm Title

placebo group

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

PRF

Intervention Description

patients who will receive PRF suspension

Intervention Type

Biological

Intervention Name(s)

placebo group

Intervention Description

patients who will receive Placebo

Primary Outcome Measure Information:

Title

Scar formation

Description

Appearance of operative scar diagnose by cardiothoracic surgeon

Time Frame

post operative- until release from hospitalization up to 1 month

Title

Wound Infection

Description

wound infection incidence diagnose by cardiothoracic surgeon

Time Frame

post operative- until release from hospitalization up to 1 month

Title

Bruising

Description

Average Bruise Change diagnose by cardiothoracic surgeon

Time Frame

post operative- until release from hospitalization up to 1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmad Reza Jodati, CTS

Phone

0413 33349525

Jodatia@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Peyman Keyhanvar

Phone

0914 114 6863

drkeyhanvar@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohammad Nouri, Ph.D

Organizational Affiliation

Head of SCARM Institute

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ahmad Reza Jodati, CTS

Organizational Affiliation

SCARM institute

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Peyman Keyhanvar, MD, Ph.D

Organizational Affiliation

Deputy for translational medicine of SCARM institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

SCARM

City

Tabriz

State/Province

East Azarbyjan

ZIP/Postal Code

0413

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sepideh jalilzade, MSc

Phone

04133349525

First Name & Middle Initial & Last Name & Degree

Sepideh Jalilzadeh, Msc

First Name & Middle Initial & Last Name & Degree

Yousef Faridvand, Ph.D

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24459346

Citation

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.

Results Reference

result

PubMed Identifier

23692143

Citation

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.

Results Reference

result

PubMed Identifier

26557476

Citation

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.

Results Reference

result

Learn more about this trial

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

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