PRF With Topical Antibiotics or Antiseptics in Chronical Wounds Version 1.4 (PRF-TAT)
Chronic Skin Ulcer
About this trial
This is an interventional treatment trial for Chronic Skin Ulcer
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
Sites / Locations
- Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
Study arm 1 - PRF plus amikacin and teicoplanin
Study arm 2 - PRF plus normal saline
Study arm 3 - PRF mixed with PHMB plus Macrogolol
Study arm 4 - Acticoat 7
PRF mixed with amikacin and teicoplanin is sprayed on the patients' ulcer
PRF mixed with normal saline is sprayed on the patients' ulcer
PRF mixed with polyhexanide and macrogolol is sprayed on the patients' ulcer
A silver gauze (Acticoat 7®) is applied to the patients' ulcer