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

NCT06103812 | Unknown

• 1 other identifier: AQG06-21-01
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• EQ5D-Patient's quality of life

  56 days

• Performance of treatment

  7,21,28,42 and 56 days

• Safety and Tollerability

  56 days

Study Arms (1)

Hyalo4 Skin Gel

Device: Hyalo4 Skin Gel

Interventions

Hyalo4 Skin Gel DEVICE

The evaluation of performance and safety of Hyalo4 Skin Gel in the amelioration of bed wound appearance after 14 days of treatment.

Hyalo4 Skin Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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),

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (6)

Nemocnica Ružinov

Bratislava, 82606, Slovakia

RECRUITING

BeneDerma s.r.o.

Bratislava, 84102, Slovakia

RECRUITING

Pedi-Derma s.r.o.

Košice, 04001, Slovakia

RECRUITING

POLIKLINIKA ProCare KVP

Košice, 04023, Slovakia

RECRUITING

Nemocnica s poliklinikou Spišská Nová Ves, a.s.

Spišská Nová Ves, 05201, Slovakia

RECRUITING

Fakultná nemocnica s poliklinikou Žilina

Žilina, 01207, Slovakia

RECRUITING

Central Study Contacts

Niocola Giordan

CONTACT

+39 349 823 2111; ngiordan@fidiapharma.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 27, 2023
• Study Start: March 24, 2022
• Primary Completion: August 28, 2023
• Study Completion: January 31, 2024
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

SL (6)