Evaluating a hyaluronic acid medical device for post-surgical wound healing
Randomized Controlled Study to Evaluate the Performance and Safety of a Linear Hyaluronic Acid-based Medical Device in the Treatment of Wounds
This study is testing a new hyaluronic acid device to see if it helps adults heal better and feel less pain after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nova Argentia S.r.l. Industry-sponsored |
| Locations | 1 site (Acireale, Catania) |
| Trial ID | NCT06284538 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and effectiveness of a Class IIB medical device that utilizes linear hyaluronic acid for treating post-surgical wounds. The evaluation will focus on various parameters, including the Clinical Healing score, the percentage of patients with completely healed wounds by day 30, and the pain experienced during dressing changes. The study will involve adult patients who have undergone surgery and will monitor for any adverse events throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients with post-surgical wounds who can comply with the study protocol.
Not a fit: Patients who are pregnant, breastfeeding, or have certain medical conditions such as immunodeficiencies or oncology diagnoses may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve wound healing outcomes and reduce pain for patients with post-surgical wounds.
How similar studies have performed: While the use of hyaluronic acid in wound healing has been explored, this specific application with a Class IIB medical device is relatively novel and may provide new insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult patients with post-surgical wounds * subjects capable of complying with the protocol procedures * signing of informed consent Exclusion Criteria: * Pregnancy or breastfeeding * inadequate contraceptive procedures in fertile women * chronic concomitant treatment with local antiseptics, use of anti-inflammatory drugs (steroids and non-steroids), analgesics, antineoplastics or immunosuppressants * non-therapeutic use of psychoactive substances, drug and/or alcohol abuse * immunodeficiencies (including HIV infection) * Oncology patients; * known allergies, hypersensitivity or intolerance to any of the substances administered in this study * any medical or non-medical condition that may significantly reduce the possibility of obtaining reliable data and achieving the objectives of the study * Participation in clinical trials with devices or drugs within 3 months prior to the screening visit.
Where this trial is running
Acireale, Catania
- Casa di cura riabilitativa Villa Sofia — Acireale, Catania, Italy (Recruiting)
Study contacts
- Study coordinator: Marco Daniele, PI
- Email: marcodaniele@email.it
- Phone: 0957631997
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.