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PRF With Topical Antibiotics or Antiseptics in Chronical Wounds Version 1.4

NCT02652169 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-04-07

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Florian Thalhammer, Prof. Dr. · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2025-12-31
Completion
2027-04-30

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02652169 on ClinicalTrials.gov