Management of Acute and Chronic Wounds With Hyaluronic Acid

Launched by FIDIA FARMACEUTICI S.P.A. · Oct 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Connettivina Bio, which is a gel made from hyaluronic acid, to see how well it helps heal different types of wounds, including burns, surgical wounds, and pressure ulcers. The goal is to assess both the effectiveness and safety of this treatment when used with a special dressing system in various healthcare settings across Italy.

To be eligible for this trial, participants need to be at least 18 years old and have a wound that is between 10 and 100 square centimeters in size. They should be treated with Connettivina Bio on an outpatient basis, meaning they won’t be hospitalized. However, people with infected wounds, those who are currently hospitalized, or anyone with conditions that make their wounds more likely to get infected will not be able to join. Participants will need to give their written consent and can expect to be closely monitored throughout the study to see how well the treatment works for their healing process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed written informed consent.
• • 2. Male or female ≥18 years.
• • 3. Patients selected to be treated with Connettivina Bio.
• • 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. 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
• • Conditions associated with hypoxia and/or poor tissue perfusion
• • Corticosteroid, cytotoxic or immunosuppressive therapy.
• • 5. 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.