PRF With Topical Antibiotics or Antiseptics in Chronical Wounds Version 1.4

NCT ID: NCT02652169

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2027-04-30

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 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.

Conditions

Chronic Skin Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Study arm 1 - PRF plus amikacin and teicoplanin

PRF mixed with amikacin and teicoplanin is sprayed on the patients' ulcer

Group Type: EXPERIMENTAL

PRF mixed with amikacin and teicoplanin

Intervention Type: DRUG

PRF, mixed with amikacin and teicoplanin is applied to the chronic ulcer

Study arm 2 - PRF plus normal saline

PRF mixed with normal saline is sprayed on the patients' ulcer

Group Type: EXPERIMENTAL

PRF plus normal saline

Intervention Type: DRUG

PRF as a monosubstance plus sodium chloride 0.9% is applied to the chronic ulcer

Study arm 3 - PRF mixed with PHMB plus Macrogolol

PRF mixed with polyhexanide and macrogolol is sprayed on the patients' ulcer

Group Type: EXPERIMENTAL

PRF mixed with PHMB plus Macrogolol

Intervention Type: DRUG

PRF, mixed with Lavasorb is applied to the chronic ulcer

Study arm 4 - Acticoat 7

A silver gauze (Acticoat 7®) is applied to the patients' ulcer

Group Type: ACTIVE_COMPARATOR

Silver gauze

Intervention Type: OTHER

Acticoat 7 silver wound dressing is applied to the chronic ulcer

Interventions

PRF mixed with amikacin and teicoplanin

PRF, mixed with amikacin and teicoplanin is applied to the chronic ulcer

Intervention Type: DRUG

PRF mixed with PHMB plus Macrogolol

PRF, mixed with Lavasorb is applied to the chronic ulcer

Intervention Type: DRUG

PRF plus normal saline

PRF as a monosubstance plus sodium chloride 0.9% is applied to the chronic ulcer

Intervention Type: DRUG

Silver gauze

Acticoat 7 silver wound dressing is applied to the chronic ulcer

Intervention Type: OTHER

Other Intervention Names

PRF plus amikacin/teicoplanin; PRF plus Lavasorb; PRF plus sodium chloride 0.9%; Acticoat 7

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Florian Thalhammer

Univ.-Prof. Dr.med.univ.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Florian Thalhammer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Florian Thalhammer, Prof. Dr.

Role: CONTACT

0043140400 ext. 44400

Facility Contacts

Florian Thalhammer, Prof. MD

Role: primary

florian.thalhammer@meduniwien.ac.at

0043140400 ext. 4440

Other Identifiers

PRF-TAT

Identifier Type: -

Identifier Source: org_study_id