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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm 1 - PRF plus amikacin and teicoplanin | Experimental | PRF mixed with amikacin and teicoplanin is sprayed on the patients' ulcer |
|
| Study arm 2 - PRF plus normal saline | Experimental | PRF mixed with normal saline is sprayed on the patients' ulcer |
|
| Study arm 3 - PRF mixed with PHMB plus Macrogolol | Experimental | PRF mixed with polyhexanide and macrogolol is sprayed on the patients' ulcer |
|
| Study arm 4 - Acticoat 7 | Active Comparator | A silver gauze (Acticoat 7®) is applied to the patients' ulcer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRF mixed with amikacin and teicoplanin | Drug | PRF, mixed with amikacin and teicoplanin is applied to the chronic ulcer |
|
| Measure | Description | Time Frame |
|---|---|---|
| reduction in wound area | day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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:
Wound size ≥ 5 cm2 and < 200 cm2
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florian Thalhammer, Prof. Dr. | Contact | 0043140400 | 44400 |
| Name | Affiliation | Role |
|---|---|---|
| Florian Thalhammer, Prof. Dr. | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | 1190 | Austria |
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| ID | Term |
|---|---|
| D000583 | Amikacin |
| D017334 | Teicoplanin |
| D056690 | Prolactin-Releasing Hormone |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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|
| PRF mixed with PHMB plus Macrogolol | Drug | PRF, mixed with Lavasorb is applied to the chronic ulcer |
|
|
| PRF plus normal saline | Drug | PRF as a monosubstance plus sodium chloride 0.9% is applied to the chronic ulcer |
|
|
| Silver gauze | Other | Acticoat 7 silver wound dressing is applied to the chronic ulcer |
|
|
| 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 |
| Occurrence of drug resistant bacteria in a swab of the tissue surrounding the wound or a Z-swab of the torso | on day 28 and 56 |
| D000077427 |
| Lipoglycopeptides |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |