PRF With Topical Antibiotics or Antiseptics in Chronical Wounds Version 1.4

NCT02652169 | Recruiting DMC

• 1 other identifier: PRF-TAT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• reduction in wound area

  day 56

Secondary Outcomes (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)

  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

Study Arms (4)

Study arm 1 - PRF plus amikacin and teicoplanin

EXPERIMENTAL

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

Drug: PRF mixed with amikacin and teicoplanin

Study arm 2 - PRF plus normal saline

EXPERIMENTAL

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

Drug: PRF plus normal saline

Study arm 3 - PRF mixed with PHMB plus Macrogolol

EXPERIMENTAL

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

Drug: PRF mixed with PHMB plus Macrogolol

Study arm 4 - Acticoat 7

ACTIVE COMPARATOR

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

Other: Silver gauze

Interventions

PRF mixed with amikacin and teicoplanin DRUG

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

Also known as: PRF plus amikacin/teicoplanin

Study arm 1 - PRF plus amikacin and teicoplanin

PRF mixed with PHMB plus Macrogolol DRUG

PRF, mixed with Lavasorb is applied to the chronic ulcer

Also known as: PRF plus Lavasorb

Study arm 3 - PRF mixed with PHMB plus Macrogolol

PRF plus normal saline DRUG

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

Also known as: PRF plus sodium chloride 0.9%

Study arm 2 - PRF plus normal saline

Silver gauze OTHER

Acticoat 7 silver wound dressing is applied to the chronic ulcer

Also known as: Acticoat 7

Study arm 4 - Acticoat 7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1190, Austria

RECRUITING

MeSH Terms

Interventions

Amikacin; Teicoplanin; Prolactin-Releasing Hormone; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Lipoglycopeptides; Glycopeptides; Glycoconjugates; Peptides; Amino Acids, Peptides, and Proteins; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Nerve Tissue Proteins; Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Florian Thalhammer, Prof. Dr.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian Thalhammer, Prof. Dr.

CONTACT

0043140400

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr.med.univ.

Study Record Dates

• First Submitted: July 17, 2015
• First Posted: January 11, 2016
• Study Start: June 1, 2014
• Primary Completion: December 1, 2025
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 7, 2022

Record last verified: 2022-04

Locations

AU (1)