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

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Medical University of Vienna
RECRUITING
Vienna
Contact Information
Primary
Florian Thalhammer, Prof. Dr.
0043140400
Time Frame
Start Date: 2014-06
Estimated Completion Date: 2027-04
Participants
Target number of participants: 120
Treatments
Experimental: Study arm 1 - PRF plus amikacin and teicoplanin
PRF mixed with amikacin and teicoplanin is sprayed on the patients' ulcer
Experimental: Study arm 2 - PRF plus normal saline
PRF mixed with normal saline is sprayed on the patients' ulcer
Experimental: Study arm 3 - PRF mixed with PHMB plus Macrogolol
PRF mixed with polyhexanide and macrogolol is sprayed on the patients' ulcer
Active_comparator: Study arm 4 - Acticoat 7
A silver gauze (Acticoat 7®) is applied to the patients' ulcer
Related Therapeutic Areas
Sponsors
Leads: Medical University of Vienna

This content was sourced from clinicaltrials.gov