Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyalo4 Skin Gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyalo4 Skin Gel | Device | The evaluation of performance and safety of Hyalo4 Skin Gel in the amelioration of bed wound appearance after 14 days of treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 56 days |
| Performance of treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients < 18 years.
Patients with acute or chronic infected lesions.
Hospitalized patients.
Women who are pregnant or breastfeeding or women who could become pregnant and are not using effective contraception.
Patients with acute or chronic lesions at high risk of infection, presenting at least one of the following criteria:
Subjects unable to understand informed consent or having a high probability of non-compliance with the study procedures and or non-completion of the study according to investigator's judgement
Not provided
Not provided
Not provided
Patients with acute or chronic wounds of different etiology (first and second degree burns; surgical wounds; vascular ulcers; metabolic ulcers; pressure ulcers),
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Niocola Giordan | Contact | +39 349 823 2111 | ngiordan@fidiapharma.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemocnica Ružinov | Recruiting | Bratislava | 82606 | Slovakia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| 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. | 56 days |
| BeneDerma s.r.o. | Recruiting | Bratislava | 84102 | Slovakia |
|
| Pedi-Derma s.r.o. | Recruiting | Košice | 04001 | Slovakia |
|
| POLIKLINIKA ProCare KVP | Recruiting | Košice | 04023 | Slovakia |
|
| Nemocnica s poliklinikou Spišská Nová Ves, a.s. | Recruiting | Spišská Nová Ves | 05201 | Slovakia |
|
| Fakultná nemocnica s poliklinikou Žilina | Recruiting | Žilina | 01207 | Slovakia |
|