Wound Heal Clinical Trial
Official title:
Prospective, Multicentric, Post-market Clinical Investigation to Evaluate the Performance and Safety of Connettivina Bio Line in Management of Acute and Chronic Wounds
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.
Status | Recruiting |
Enrollment | 170 |
Est. completion date | September 30, 2024 |
Est. primary completion date | February 28, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | AOU Ospedali Riuniti SOD-Clinica di Chirurgia Plastica e Ricostruttiva | Ancona | |
Italy | Centro Grandi Ustionati OSPEDALE BUFALINI DI CESENA - (FC) | Cesena | Forlì-Cesena |
Italy | Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - SC (UCO) | Trieste |
Lead Sponsor | Collaborator |
---|---|
Fidia Farmaceutici s.p.a. |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the performance of Connettivina Bio line in the amelioration of wound bed appearance | The performance of Connettivina Bio line, in the amelioration of wound bed appearance, will be evaluated from baseline up to 14 days of treatment. The percentage of patients showing a change in at least of one of the following evaluated 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 | Number of Participants With Treatment-Related Adverse Events | The safety and tolerability of Connettivina Bio will be assessed throughout all the visits by investigating local and expected adverse events, as a consequence of the product application. Additionally, any other adverse event occurred during the study will be considered and evaluated | 8 weeks |
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