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

Last updated: October 26, 2023
Sponsor: Fidia Farmaceutici s.p.a.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Hyalo4 Skin Gel

Clinical Study ID

NCT06103812
AQG06-21-01
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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; surgicalwounds; vascular ulcers; metabolic ulcers; pressure ulcers.
  5. Patients followed on an outpatient or home basis.
  6. Wound area ≥ 10 cm2 and ≤ 100 cm2

Exclusion

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 notusing effective contraception.
  5. Patients with acute or chronic lesions at high risk of infection, presenting at leastone 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 10cigarettes/day)
  • Conditions associated with hypoxia and/or poor tissue perfusion
  • Corticosteroid, cytotoxic or immunosuppressive therapy.
  1. Subjects unable to understand informed consent or having a high probability ofnon-compliance with the study procedures and or non-completion of the study accordingto investigator's judgement

Study Design

Total Participants: 170
Treatment Group(s): 1
Primary Treatment: Hyalo4 Skin Gel
Phase:
Study Start date:
March 24, 2022
Estimated Completion Date:
January 31, 2024

Study 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.

Connect with a study center

  • BeneDerma s.r.o.

    Bratislava, 84102
    Slovakia

    Active - Recruiting

  • Nemocnica Ružinov

    Bratislava, 82606
    Slovakia

    Active - Recruiting

  • POLIKLINIKA ProCare KVP

    Košice, 04023
    Slovakia

    Active - Recruiting

  • Pedi-Derma s.r.o.

    Košice, 04001
    Slovakia

    Active - Recruiting

  • Nemocnica s poliklinikou Spišská Nová Ves, a.s.

    Spišská Nová Ves, 05201
    Slovakia

    Active - Recruiting

  • Fakultná nemocnica s poliklinikou Žilina

    Žilina, 01207
    Slovakia

    Active - Recruiting

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