Evaluating Hyalo4 Skin Gel for Wound Management

Prospective, Multicentric, Observational Clinical Investigation to Evaluate the Performance and Safety of Hyalo4 Skin Gel in Management of Acute and Chronic Wounds.

This study tests if Hyalo4 Skin Gel can help heal different types of wounds better and safely over eight weeks for people with both new and ongoing wounds.

Quick facts

• Study type: Observational
• Enrollment: 170 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fidia Farmaceutici s.p.a. (industry)
• Locations: 6 sites (Bratislava and 5 other locations)
• Trial ID: NCT06103812 on ClinicalTrials.gov

What this trial studies

This clinical investigation evaluates the performance and safety of Hyalo4 Skin Gel in managing both acute and chronic wounds of various causes. The study involves a maximum of seven visits over a period of eight weeks, with the first four visits occurring within the first month. Patients will receive daily medication changes according to clinical practice and the product's instructions for use. The study aims to assess the gel's effectiveness in promoting wound healing.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with specific types of wounds such as burns, surgical wounds, and ulcers.

Not a fit: Patients with infected lesions, those hospitalized, or individuals with high-risk conditions for infection may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective treatment option for patients with difficult-to-heal wounds.

How similar studies have performed: While similar studies have explored wound management techniques, the specific use of Hyalo4 Skin Gel in this context is relatively novel.

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

Where this trial is running

Bratislava and 5 other locations

• Nemocnica Ružinov — Bratislava, Slovakia (RECRUITING)
• BeneDerma s.r.o. — Bratislava, Slovakia (RECRUITING)
• Pedi-Derma s.r.o. — Košice, Slovakia (RECRUITING)
• POLIKLINIKA ProCare KVP — Košice, Slovakia (RECRUITING)
• Nemocnica s poliklinikou Spišská Nová Ves, a.s. — Spišská Nová Ves, Slovakia (RECRUITING)
• Fakultná nemocnica s poliklinikou Žilina — Žilina, Slovakia (RECRUITING)

Study contacts

• Study coordinator: Niocola Giordan

Conditions: Wound Heal