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PRF With Topical Antibiotics or Antiseptics in Chronical Wounds Version 1.4

RecruitingNAAges 18 Years - anyAllMedical University of Vienna
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In plain words

What the trial is, and whether it could suit you

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 monotherapy as well as a growth promoting carrier matrix for antimicrobial compounds. The investigators therefore designed a four armed trial with three PRF arms which are compared to each other as well as to an active comparator. The treatment arms are as follows: Study arm 1: PRF with amikacin and teicoplanin Study arm 2: PRF with placebo (0.9% sodium chloride) Study arm 3: PRF with PHMB (polyhexanid) plus Macrogolol (Lavasorb®) Study arm 4: Acticoat 7® wound dressing as active control Patients with infected chronic wounds may be included in this trial. Infection shall be diagnosed by an experienced senior infectious diseases specialist. Patients with untreated peripheral vascular occlusive dis

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • PRF mixed with amikacin and teicoplanin
  • PRF mixed with PHMB plus Macrogolol
  • PRF plus normal saline
  • Silver gauze
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Where

1 site
Medical University of Vienna
Vienna, Austria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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