Evaluate the performance and safety of the use of Hyalo4 Skin Gel in terms of wound management
Ths clinical investigation study is to evaluate the performance and safety of Hyalo4 Skin Gel in the management of acute or chronic wounds of different etiology, according to the indication for use, the prescriptions of the clinicians and the standard procedures of the sites. A maximum of 7 Visits will be performed, with the first 4 visits performed over a 4-weeks period for each patient and the last visit after 8 weeks from the first visit. The schedule treatment will consist of daily medication changes, according to the instruction for use and the clinical practice.
Study Type
OBSERVATIONAL
Enrollment
170
The evaluation of performance and safety of Hyalo4 Skin Gel in the amelioration of bed wound appearance after 14 days of treatment.
Nemocnica Ružinov
Bratislava, Slovakia
RECRUITINGBeneDerma s.r.o.
Bratislava, Slovakia
RECRUITINGPedi-Derma s.r.o.
Košice, Slovakia
Performance of Hyalo4 Skin Gel treatment
The outcome will be measured as percentage of patients showing positive change in at least one of the following parameters: amelioration of wound tissue type (necrotic, slough, granulation tissue, epithelial tissue, closed), decrease of exudate amount (dry, moist, slightly exuding, heavily exuding, wet) and amelioration of exudate type (bloody, bloody/purulent, clear, murky, purulent, serous).
Time frame: 14 days
EQ5D-Patient's quality of life
Patient's quality of life assessment will be evaluated as a change from baseline to 56 days after the start of treatment, through administration of EuroQoL-5D (EQ-5D).
Time frame: 56 days
Performance of treatment
The performance of Hyalo4 Skin Gel will be evaluated from baseline to 7, 21, 28, 42 and 56 days as amelioration of wound bed appearance in terms of: type of wound bed tissue and exudate quantity and quality.
Time frame: 7,21,28,42 and 56 days
Safety and Tollerability
The safety and tolerability of Hyalo4 Skin Gel will be assessed throughout all the visits by investigating local and expected adverse events, as consequence of the product application and any other adverse event occurred during the study.
Time frame: 56 days
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POLIKLINIKA ProCare KVP
Košice, Slovakia
RECRUITINGNemocnica s poliklinikou Spišská Nová Ves, a.s.
Spišská Nová Ves, Slovakia
RECRUITINGFakultná nemocnica s poliklinikou Žilina
Žilina, Slovakia
RECRUITING