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PRF-TAT
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
Sponsor study identifier
interventional
120
1 country
1
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
July 17, 2015
Actual (reported)January 11, 2016
Actual (reported)December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
reduction in wound area
day 56
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)
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)
day 0, 7, 14, 21, 28, 35, 42, 49, 56
time to sterility of the wound
day 0, 7, 14, 21, 28, 35, 42, 49, 56
Relative wound volume and wound area reduction
on day 28 and 56
Occurrence of drug resistant bacteria in the wound
day 0, 7, 14, 21, 28, 35, 42, 49, 56
PRF mixed with amikacin and teicoplanin is sprayed on the patients' ulcer
PRF mixed with normal saline is sprayed on the patients' ulcer
PRF mixed with polyhexanide and macrogolol is sprayed on the patients' ulcer
PRF, mixed with amikacin and teicoplanin is applied to the chronic ulcer
PRF, mixed with Lavasorb is applied to the chronic ulcer
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
PRF mixed with amikacin and teicoplanin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordMedical University of Vienna
Vienna, 1190, Austria
Florian Thalhammer, Prof. Dr.
Medical University of Vienna
First Submitted
July 17, 2015
First Posted
January 11, 2016
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
A silver gauze (Acticoat 7®) is applied to the patients' ulcer
PRF as a monosubstance plus sodium chloride 0.9% is applied to the chronic ulcer
Acticoat 7 silver wound dressing is applied to the chronic ulcer
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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December 2025
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 7, 2022
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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