Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06108999

Management of Acute and Chronic Wounds With Hyaluronic Acid

Led by Fidia Farmaceutici s.p.a. · Updated on 2024-05-09

170

Participants Needed

3

Research Sites

113 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the performance and safety of Connettivina Bio, when used in the management of wounds. Moreover, the study will evaluate the correlation of the 'dressing system' (formed by the Connettivina Bio primary dressing plus a secondary one) used in different care settings. The study will include Italian healthcare facilities.

CONDITIONS

Official Title

Management of Acute and Chronic Wounds With Hyaluronic Acid

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed written informed consent
  • Male or female aged 18 years or older
  • Patients selected to be treated with Connettivina Bio
  • Patients with wounds from first and second degree burns, surgical wounds, vascular ulcers, metabolic ulcers, or pressure ulcers
  • Patients followed on an outpatient or home basis
  • Wound area between 10 cm2 and 100 cm2
Not Eligible

You will not qualify if you...

  • Patients under 18 years old
  • Patients with acute or chronic infected lesions
  • Hospitalized patients
  • Patients with acute or chronic lesions at high risk of infection, including those with stalled wounds showing no healing progression
  • Patients with immune system disorders
  • Patients with protein-energy malnutrition
  • Patients with alcohol, smoking, or drug abuse
  • Patients with conditions causing hypoxia or poor tissue perfusion
  • Patients receiving corticosteroid, cytotoxic, or immunosuppressive therapy
  • Subjects unable to understand informed consent or likely to not comply with study procedures or complete the study according to investigator's judgment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Centro Grandi Ustionati OSPEDALE BUFALINI DI CESENA - (FC)

Cesena, Forlì-Cesena, Italy, 47521

Not Yet Recruiting

2

AOU Ospedali Riuniti SOD-Clinica di Chirurgia Plastica e Ricostruttiva

Ancona, Italy, 60127

Actively Recruiting

3

Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - SC (UCO)

Trieste, Italy, 34121

Not Yet Recruiting

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Research Team

N

Niocola Giordan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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