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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1
Medical University of Vienna
Vienna, Austria, 1190