PRF With Topical Antibiotics or Antiseptics in Chronical Wounds Version 1.4

Launched by MEDICAL UNIVERSITY OF VIENNA · Jan 7, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called platelet-rich fibrin (PRF) for people with chronic skin ulcers that are infected. The researchers want to find out if PRF can help heal these wounds when used alone or combined with topical antibiotics or antiseptics. There are four groups in the study: one receiving PRF with antibiotics, one with a placebo (which is a salt solution), another with a different antiseptic combination, and a fourth group using a standard wound dressing.

To be eligible, participants need to be at least 18 years old and have a chronic venous ulcer with signs of localized infection. However, those with untreated diabetes, severe blood circulation issues, or certain other health conditions cannot join. If you participate, you will receive treatment for 56 days, during which your wound's healing progress will be monitored at 28 and 56 days. The study aims to help improve healing options for chronic wounds and gather important information about the effectiveness of PRF therapy.

Gender

ALL

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