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PRF With Topical Antibiotics or Antiseptics in Chronical Wounds Version 1.4 (PRF-TAT)

Primary Purpose

Chronic Skin Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
PRF mixed with amikacin and teicoplanin
PRF mixed with PHMB plus Macrogolol
PRF plus normal saline
Silver gauze
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Skin Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Study arm 1 - PRF plus amikacin and teicoplanin

Study arm 2 - PRF plus normal saline

Study arm 3 - PRF mixed with PHMB plus Macrogolol

Study arm 4 - Acticoat 7

Arm Description

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

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

Outcomes

Primary Outcome Measures

reduction in wound area

Secondary Outcome Measures

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)
Elevation of C-reactive protein over 7 mg/dl (normal value 0.5 mg/dl)
time to sterility of the wound
Relative wound volume and wound area reduction
Occurrence of drug resistant bacteria in the wound
Occurrence of drug resistant bacteria in a swab of the tissue surrounding the wound or a Z-swab of the torso

Full Information

First Posted
July 17, 2015
Last Updated
April 6, 2022
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT02652169
Brief Title
PRF With Topical Antibiotics or Antiseptics in Chronical Wounds Version 1.4
Acronym
PRF-TAT
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
April 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Skin Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study arm 1 - PRF plus amikacin and teicoplanin
Arm Type
Experimental
Arm Description
PRF mixed with amikacin and teicoplanin is sprayed on the patients' ulcer
Arm Title
Study arm 2 - PRF plus normal saline
Arm Type
Experimental
Arm Description
PRF mixed with normal saline is sprayed on the patients' ulcer
Arm Title
Study arm 3 - PRF mixed with PHMB plus Macrogolol
Arm Type
Experimental
Arm Description
PRF mixed with polyhexanide and macrogolol is sprayed on the patients' ulcer
Arm Title
Study arm 4 - Acticoat 7
Arm Type
Active Comparator
Arm Description
A silver gauze (Acticoat 7®) is applied to the patients' ulcer
Intervention Type
Drug
Intervention Name(s)
PRF mixed with amikacin and teicoplanin
Other Intervention Name(s)
PRF plus amikacin/teicoplanin
Intervention Description
PRF, mixed with amikacin and teicoplanin is applied to the chronic ulcer
Intervention Type
Drug
Intervention Name(s)
PRF mixed with PHMB plus Macrogolol
Other Intervention Name(s)
PRF plus Lavasorb
Intervention Description
PRF, mixed with Lavasorb is applied to the chronic ulcer
Intervention Type
Drug
Intervention Name(s)
PRF plus normal saline
Other Intervention Name(s)
PRF plus sodium chloride 0.9%
Intervention Description
PRF as a monosubstance plus sodium chloride 0.9% is applied to the chronic ulcer
Intervention Type
Other
Intervention Name(s)
Silver gauze
Other Intervention Name(s)
Acticoat 7
Intervention Description
Acticoat 7 silver wound dressing is applied to the chronic ulcer
Primary Outcome Measure Information:
Title
reduction in wound area
Time Frame
day 56
Secondary Outcome Measure Information:
Title
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
Title
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
Title
time to sterility of the wound
Time Frame
day 0, 7, 14, 21, 28, 35, 42, 49, 56
Title
Relative wound volume and wound area reduction
Time Frame
on day 28 and 56
Title
Occurrence of drug resistant bacteria in the wound
Time Frame
day 0, 7, 14, 21, 28, 35, 42, 49, 56
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florian Thalhammer, Prof. Dr.
Phone
0043140400
Ext
44400
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florian Thalhammer, Prof. Dr.
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1190
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian Thalhammer, Prof. MD
Phone
0043140400
Ext
4440
Email
florian.thalhammer@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Florian Thalhammer, Prof. MD
First Name & Middle Initial & Last Name & Degree
Daniela A Knafl, Dr.
First Name & Middle Initial & Last Name & Degree
Matthias G Vossen, Dr.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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PRF With Topical Antibiotics or Antiseptics in Chronical Wounds Version 1.4

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