Evaluate Performance and Safety of Hyalo4 Skin in Acute and Chronic Wounds

Fidia Pharma

Status: Enrolling

Conditions: Wound Heal

Treatments: Device: Hyalo4 Skin Gel

Study type: Observational

Funder types: Industry

Identifiers

NCT06103812

AQG06-21-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

170 participants in 1 patient group

Hyalo4 Skin Gel

Treatment:

Device: Hyalo4 Skin Gel