PRF With Topical Antibiotics or Antiseptics in Chronical Wounds Version 1.4

Official title

Platelet Rich Fibrin in Combination With Topical Antibiotics or Antiseptics in the Treatment of Chronic Wounds - a Prospective, Randomized, Active Controlled, Double Blind Pilot Trial With an Observer-blinded Control Group

Overview

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 disease as defined by an ABI (ancle brachial index) of \< 0,7 are excluded from the trial as are patients with an uncontrolled diabetes mellitus or patients who have not received sufficient treatment for a diabetic foot syndrome. Any underlying illness will be treated following standard of care. In case of chronic venous insufficiency four-layered compression bandages will be applied each visit if tolerated by the patient. Alternatively compression stockings (Class III) are permitted. This is mentioned as "Disease specific treatment" in the protocol. Patients will receive treatment for 56 days. After 28 and 56 days the wound surface will be compared to the baseline. Infection parameters (c-reactive protein and leucocyte count) will be measured weekly. Evaluation of systemic antimicrobial therapy will be performed at each visit. Systemic antimicrobial therapy is started at the discretion of a senior infectious diseases specialist.

Interventions

• Drug PRF mixed with amikacin and teicoplanin
  PRF, mixed with amikacin and teicoplanin is applied to the chronic ulcer
• Drug PRF mixed with PHMB plus Macrogolol
  PRF, mixed with Lavasorb is applied to the chronic ulcer
• Drug PRF plus normal saline
  PRF as a monosubstance plus sodium chloride 0.9% is applied to the chronic ulcer
• Other Silver gauze
  Acticoat 7 silver wound dressing is applied to the chronic ulcer

Primary outcome measures

• reduction in wound area [Time frame: day 56]

Secondary outcome measures (6)

• Number of patients in necessity to initiate systemic antimicrobial therapy based on the opinion of a senior infectious disease consultant arises (subjective assessment based on wound inflammation, serum c-reactive protein levels and leucocyte count) [Time frame: day 0, 7, 14, 21, 28, 35, 42, 49, 56]
• Elevation of C-reactive protein over 7 mg/dl (normal value 0.5 mg/dl) [Time frame: day 0, 7, 14, 21, 28, 35, 42, 49, 56]
• time to sterility of the wound [Time frame: day 0, 7, 14, 21, 28, 35, 42, 49, 56]
• Relative wound volume and wound area reduction [Time frame: on day 28 and 56]
• Occurrence of drug resistant bacteria in the wound [Time frame: day 0, 7, 14, 21, 28, 35, 42, 49, 56]
• Occurrence of drug resistant bacteria in a swab of the tissue surrounding the wound or a Z-swab of the torso [Time frame: on day 28 and 56]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Austria · 1 center

• Medical University of Vienna — Vienna

Identifiers

NCT: NCT02652169 · PRF-TAT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗