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

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06103812
• Other study ID #: AQG06-21-01
• Status: Recruiting
• Start date: March 24, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: October 2023
• Source: Fidia Farmaceutici s.p.a.
• Contact: Niocola Giordan
• Phone: +39 349 823 2111
• Email: ngiordan[@]fidiapharma.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: January 31, 2024
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound Heal
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Slovakia	Fakultná nemocnica s poliklinikou Žilina	Žilina
Slovakia	BeneDerma s.r.o.	Bratislava
Slovakia	Nemocnica Ružinov	Bratislava
Slovakia	Pedi-Derma s.r.o.	Košice
Slovakia	POLIKLINIKA ProCare KVP	Košice
Slovakia	Nemocnica s poliklinikou Spišská Nová Ves, a.s.	Spišská Nová Ves

Sponsors (1)

Lead Sponsor	Collaborator
Fidia Farmaceutici s.p.a.

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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