Clinical trial NCT06103812: Evaluate Performance and Safety of Hyalo4 Skin in Acute and Chronic Wounds
Official title: Prospective, Multicentric, Observational Clinical Investigation to Evaluate the Performance and Safety of Hyalo4 Skin Gel in Management of Acute and Chronic Wounds.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Wound Heal
Lead sponsor: Fidia Farmaceutici s.p.a.
Sponsor class: INDUSTRY
First posted: 2023-10-27
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute or chronic wounds of different etiology (first and second degree burns; surgical wounds; vascular ulcers; metabolic ulcers; pressure ulcers),

Brief summary: Evaluate the performance and safety of the use of Hyalo4 Skin Gel in terms of wound management

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Signed written informed consent.
2. Male or female ≥18 years.
3. Patients selected to be treated with Hyalo4 Skin Gel.
4. Patients with wound of the following etiology: first and second degree burns; surgical wounds; vascular ulcers; metabolic ulcers; pressure ulcers.
5. Patients followed on an outpatient or home basis.
6. Wound area ≥ 10 cm2 and ≤ 100 cm2

Exclusion Criteria:

1. Patients \< 18 years.
2. Patients with acute or chronic infected lesions.
3. Hospitalized patients.
4. Women who are pregnant or breastfeeding or women who could become pregnant and are not using effective contraception.
5. Patients with acute or chronic lesions at high risk of infection, presenting at least one of the following criteria:

   * Stalled wound, without any clinical sign of healing progression
   * Immune system disorders
   * Protein-energy malnutrition
   * Alcohol, smoking and drug abuse (50ml of spirit, 0,5L of wine and 10 cigarettes/day)
   * Conditions associated with hypoxia and/or poor tissue perfusion
   * Corticosteroid, cytotoxic or immunosuppressive therapy.
6. 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

Primary outcomes:
measure: Performance of Hyalo4 Skin Gel treatment
timeFrame: 14 days
Secondary outcomes:
measure: EQ5D-Patient's quality of life
timeFrame: 56 days
measure: Performance of treatment
timeFrame: 7,21,28,42 and 56 days
measure: Safety and Tollerability
timeFrame: 56 days
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: Nemocnica Ružinov
city: Bratislava
country: Slovakia
facility: BeneDerma s.r.o.
city: Košice
country: Slovakia
facility: Pedi-Derma s.r.o.
city: Košice
country: Slovakia
facility: POLIKLINIKA ProCare KVP
city: Spišská Nová Ves
country: Slovakia
facility: Nemocnica s poliklinikou Spišská Nová Ves, a.s.
city: Žilina
country: Slovakia
facility: Fakultná nemocnica s poliklinikou Žilina
Study officials:
References: