Effects of Platelet Rich Fibrin (PRF) in Treatment of Non... | NCT03183973

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

NCT03183973

Sponsor

SCARM Institute, Tabriz, Iran

Status

Unknown status

Last Update Posted

Oct 27, 2020Actual

Enrollment

45Estimated

Phase

Phase 1Phase 2

Conditions

Sternal Wound Repair

Interventions

PRF
placebo group

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 5, 2020Actual

Primary Completion Date

Oct 15, 2020Estimated

Completion Date

Dec 25, 2020Estimated

First Submitted Date

May 31, 2017

First Submission Date that Met QC Criteria

Jun 9, 2017

First Posted Date

Jun 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2020

Last Update Posted Date

Oct 27, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PRF group	Experimental	patients who will receive Platelet Rich Fibrin (PFR) suspension	Biological: PRF
placebo group	Experimental		Biological: placebo group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PRF	Biological	patients who will receive PRF suspension	PRF group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmad Reza Jodati, CTS	Contact	0413 33349525		Jodatia@yahoo.com
Peyman Keyhanvar	Contact	0914 114 6863		drkeyhanvar@gmail.com

Overall Officials

Name	Affiliation	Role
Mohammad Nouri, Ph.D	Head of SCARM Institute	Study Chair
Ahmad Reza Jodati, CTS	SCARM institute	Study Director
Peyman Keyhanvar, MD, Ph.D

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SCARM	Recruiting	Tabriz	East Azarbyjan	0413	Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24459346	Result	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.
23692143	Result