NCT06103812

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 170 (estimated)
• Sponsor: Fidia Farmaceutici s.p.a. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, 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.

Conditions

• Wound Heal

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-24
• Primary completion: 2023-08-28
• Completion: 2024-01-31
• First posted: 2023-10-27
• Last updated: 2023-10-27

Locations

6 sites across 1 country: Slovakia