Status:
RECRUITING
Management of Acute and Chronic Wounds With Hyaluronic Acid
Lead Sponsor:
Fidia Farmaceutici s.p.a.
Conditions:
Wound Heal
Wound; Foot
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 syste...
Detailed Description
The primary objective of the prospective, multicentric, post-market clinical investigation is to evaluate the performance of Connettivina Bio (cream, gauze-pads) in the amelioration of wound bed appea...
Eligibility Criteria
Inclusion
- Signed written informed consent.
- Male or female ≥18 years.
- Patients selected to be treated with Connettivina Bio.
- 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
Exclusion
- Patients \< 18 years.
- Patients with acute or chronic infected lesions.
- Hospitalized patients.
- 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.
- 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.
Key Trial Info
Start Date :
July 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06108999
Start Date
July 29 2022
End Date
September 30 2024
Last Update
May 9 2024
Active Locations (3)
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1
Centro Grandi Ustionati OSPEDALE BUFALINI DI CESENA - (FC)
Cesena, Forlì-Cesena, Italy, 47521
2
AOU Ospedali Riuniti SOD-Clinica di Chirurgia Plastica e Ricostruttiva
Ancona, Italy, 60127
3
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - SC (UCO)
Trieste, Italy, 34121