Using Hyaluronic Acid for Managing Wounds
Prospective, Multicentric, Post-market Clinical Investigation to Evaluate the Performance and Safety of Connettivina Bio Line in Management of Acute and Chronic Wounds
This study is testing a hyaluronic acid cream and gauze to see if it helps improve the healing of different types of wounds and how it affects patients' quality of life over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fidia Farmaceutici s.p.a. Industry-sponsored |
| Locations | 3 sites (Cesena, Forlì-Cesena and 2 other locations) |
| Trial ID | NCT06108999 on ClinicalTrials.gov |
What this trial studies
This clinical investigation evaluates the safety and effectiveness of Connettivina Bio, a hyaluronic acid-based cream and gauze, in treating various types of wounds. The study aims to assess improvements in wound appearance over a 14-day period, focusing on changes in tissue type, exudate amount, and quality. It will also analyze the choice of dressing systems used in different healthcare settings across Italy. Secondary objectives include evaluating patient quality of life and long-term wound healing progress up to 56 days.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with specific types of wounds such as burns, surgical wounds, or ulcers, who are being treated on an outpatient basis.
Not a fit: Patients with infected lesions, those hospitalized, or individuals with conditions that increase infection risk will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve wound healing outcomes for patients with various wound types.
How similar studies have performed: While similar approaches have been explored, this specific application of Connettivina Bio in wound management is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cesena, Forlì-Cesena and 2 other locations
- Centro Grandi Ustionati OSPEDALE BUFALINI DI CESENA - (FC) — Cesena, Forlì-Cesena, Italy (Not_yet_recruiting)
- AOU Ospedali Riuniti SOD-Clinica di Chirurgia Plastica e Ricostruttiva — Ancona, Italy (Recruiting)
- Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - SC (UCO) — Trieste, Italy (Not_yet_recruiting)
Study contacts
- Study coordinator: Niocola Giordan
- Email: ngiordan@fidiapharma.it
- Phone: +39 349 823 2111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.