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

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

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

Study Overview

• Status: Recruiting
• Conditions: Wound Heal
• Intervention / Treatment: Device: Hyalo4 Skin Gel

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, 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.

• Study Type: Observational
• Enrollment (Estimated): 170

Contacts and Locations

• Study Contact: Name: Niocola Giordan; Phone Number: +39 349 823 2111; Email: ngiordan@fidiapharma.it

Study Locations

• Slovakia
  • Bratislava, Slovakia, 82606
    • Recruiting
    • Nemocnica Ruzinov
    • Contact: Rudolf Sokol
  • Bratislava, Slovakia, 84102
    • Recruiting
    • BeneDerma s.r.o.
    • Contact: Regina Paulínyová
  • Košice, Slovakia, 04001
    • Recruiting
    • Pedi-Derma s.r.o.
    • Contact: Jagienka Jautová
  • Košice, Slovakia, 04023
    • Recruiting
    • POLIKLINIKA ProCare KVP
    • Contact: Vladimír Medvecký
  • Spišská Nová Ves, Slovakia, 05201
    • Recruiting
    • Nemocnica s poliklinikou Spisska Nova Ves, a.s.
    • Contact: Edward Hulo
  • Žilina, Slovakia, 01207
    • Recruiting
    • Fakultna nemocnica s poliklinikou Zilina
    • Contact: Juraj Váňa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute or chronic wounds of different etiology (first and second degree burns; surgical wounds; vascular ulcers; metabolic ulcers; pressure ulcers),

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hyalo4 Skin Gel	Device: Hyalo4 Skin Gel; The evaluation of performance and safety of Hyalo4 Skin Gel in the amelioration of bed wound appearance after 14 days of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of Hyalo4 Skin Gel treatment	The outcome will be measured as percentage of patients showing positive change in at least one of the following parameters: amelioration of wound tissue type (necrotic, slough, granulation tissue, epithelial tissue, closed), decrease of exudate amount (dry, moist, slightly exuding, heavily exuding, wet) and amelioration of exudate type (bloody, bloody/purulent, clear, murky, purulent, serous).	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ5D-Patient's quality of life	Patient's quality of life assessment will be evaluated as a change from baseline to 56 days after the start of treatment, through administration of EuroQoL-5D (EQ-5D).	56 days
Performance of treatment	The performance of Hyalo4 Skin Gel will be evaluated from baseline to 7, 21, 28, 42 and 56 days as amelioration of wound bed appearance in terms of: type of wound bed tissue and exudate quantity and quality.	7,21,28,42 and 56 days
Safety and Tollerability	The safety and tolerability of Hyalo4 Skin Gel will be assessed throughout all the visits by investigating local and expected adverse events, as consequence of the product application and any other adverse event occurred during the study.	56 days

Collaborators and Investigators

• Sponsor: Fidia Farmaceutici s.p.a.

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2022
• Primary Completion (Actual): August 28, 2023
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: AQG06-21-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No