Status:

RECRUITING

PRF With Topical Antibiotics or Antiseptics in Chronical Wounds Version 1.4

Lead Sponsor:

Medical University of Vienna

Conditions:

Chronic Skin Ulcer

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Platelet rich fibrin (PRF) is a new therapy option for chronic wounds with yet unproven therapeutic efficacy. This randomised controlled trial aims to provide evidence of the efficacy of PRF as monoth...

Eligibility Criteria

Inclusion Criteria:

  • Males and females aged over 18 who are able to give informed consent

  • Chronic venous ulcer with localized non-systemic soft-tissue infection diagnosed by senior infectious diseases specialist based on US FDA Guidance for Industry Chronic cutaneous ulcer and burn wounds June 2006:

    • slough and necrotic tissue
    • exsudate
    • smell
    • inflammation
    • presence of granulation tissue
    • pain
  • Wound size ≥ 5 cm2 and < 200 cm2

Exclusion Criteria:

  • Non-treated diabetes mellitus, HbA1c > 12 mg/dl
  • Non treated (orthopaedic shoe) diabetic foot syndrome
  • ABI < 0,7
  • Wound size 15 cm2 and > 200 cm2
  • CRP > 5 mg/dl
  • Leucocytes > 15.000 /μl
  • Infection of another site
  • Infection of the ulcer with a pathogen with inherent resistance to amikacin and teicoplanin
  • Known osteomyelitis
  • Known erysipelas
  • Known phlegmon
  • Complicated deep tissue infection not solely treatable with PRF plus antimicrobial therapy in the opinion of a senior infectious diseases specialist
  • Planned systemic antimicrobial therapy
  • Active viral hepatitis (A/B/C) or active HIV infection or active syphilis
  • Increased sensitivity to amikacin or teicoplanin, PHMB or macrogolol
  • Increased sensitivity to tramexanic acid or batroxobin
  • Presence of neoplastic growth in the ulcer
  • Thrombocytopenic patients (<150.000 G/L)
  • Haemoglobin < 95 g/L
  • Known pregnancy or lactation
  • Severe renal impairment (creatinine clearance <30 ml/min)
  • History or clinical signs of impairment of the cochlea or vestibularis system
  • Neuromuscular diseases (i.e. Myasthenia gravis, Parkinson's disease)
  • Aminoglycoside treatment less than four weeks before inclusion
  • Other reasons opposing the study participation on the discretion of the investigators

Key Trial Info

Start Date :

June 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2027

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT02652169

Start Date

June 1 2014

End Date

April 1 2027

Last Update

April 7 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Medical University of Vienna

Vienna, Austria, 1190

PRF With Topical Antibiotics or Antiseptics in Chronical Wounds Version 1.4 | DecenTrialz