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

Launched by FIDIA FARMACEUTICI S.P.A. · Oct 26, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness and safety of a gel called Hyalo4 Skin for treating different types of wounds, including burns, surgical wounds, and pressure ulcers. The goal is to see how well this gel works in helping wounds heal and whether it is safe for patients to use. The trial is currently recruiting participants, so if you or someone you know has a wound that meets the study criteria, you might be eligible to take part.

To be included in the trial, participants need to be at least 18 years old and have a specific type of wound that is not infected. The wound must be between 10 and 100 square centimeters in size. Participants will apply the Hyalo4 Skin Gel and will be monitored during the healing process. It's important to know that certain conditions, like being pregnant, having an active infection, or using specific medications that affect the immune system, would prevent someone from joining the study. If you’re interested or have questions about the trial, it’s a good idea to talk to your healthcare provider for more information.

Gender

ALL

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