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Status:

UNKNOWN

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

Lead Sponsor:

Fidia Farmaceutici s.p.a.

Conditions:

Wound Heal

Eligibility:

All Genders

18+ years

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, t...

Eligibility Criteria

Inclusion

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

Exclusion

  • Patients \< 18 years.
  • Patients with acute or chronic infected lesions.
  • Hospitalized patients.
  • Women who are pregnant or breastfeeding or women who could become pregnant and are not using effective contraception.
  • 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.
  • 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

Key Trial Info

Start Date :

March 24 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 31 2024

Estimated Enrollment :

170 Patients enrolled

Trial Details

Trial ID

NCT06103812

Start Date

March 24 2022

End Date

January 31 2024

Last Update

October 27 2023

Active Locations (6)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (6 locations)

1

Nemocnica Ružinov

Bratislava, Slovakia, 82606

2

BeneDerma s.r.o.

Bratislava, Slovakia, 84102

3

Pedi-Derma s.r.o.

Košice, Slovakia, 04001

4

POLIKLINIKA ProCare KVP

Košice, Slovakia, 04023