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

NCT03183973 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-10-27

No results posted yet for this 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.

Conditions

  • Sternal Wound Repair

Interventions

BIOLOGICAL

PRF

patients who will receive PRF suspension

BIOLOGICAL

placebo group

patients who will receive Placebo

Sponsors & Collaborators

  • SCARM Institute, Tabriz, Iran

    lead OTHER_GOV

Principal Investigators

  • Mohammad Nouri, Ph.D · Head of SCARM Institute

  • Ahmad Reza Jodati, CTS · SCARM institute

  • Peyman Keyhanvar, MD, Ph.D · Deputy for translational medicine of SCARM institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-05
Primary Completion
2020-10-15
Completion
2020-12-25

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03183973 on ClinicalTrials.gov