Clinical trial NCT03183973: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Sternal Wound Repair
Lead sponsor: SCARM Institute, Tabriz, Iran
Sponsor class: OTHER_GOV
First posted: 2017-06-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Scar formation
timeFrame: post operative- until release from hospitalization up to 1 month
measure: Wound Infection
timeFrame: post operative- until release from hospitalization up to 1 month
measure: Bruising
timeFrame: post operative- until release from hospitalization up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: SCARM
state: East Azarbyjan
Study officials:
affiliation: Head of SCARM Institute
name: Mohammad Nouri, Ph.D
role: STUDY_CHAIR
affiliation: SCARM institute
name: Ahmad Reza Jodati, CTS
role: STUDY_DIRECTOR
affiliation: Deputy for translational medicine of SCARM institute
name: Peyman Keyhanvar, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.