Wound Healing Disorder Clinical Trial
— WOUND-HOfficial title:
Randomized Controlled Study to Evaluate the Performance and Safety of a Linear Hyaluronic Acid-based Medical Device in the Treatment of Wounds
The primary objective of the study is to evaluate the safety and performance of a Class IIB medical device based on linear hyaluronic acid used in the treatment of post-surgical wounds. The outcomes of the study are the improvement of wound healing assessed through the Clinical Healing score (score from 0 to 5), which includes the evaluation of: redness, edema, suppuration, healthy granulation tissue and signs of re-epithelialization; the percentage of patients with completely healed wounds at day 30 post-treatment; the pain perceived by the patient when changing the dressing; the frequency of adverse events.
Status | Recruiting |
Enrollment | 112 |
Est. completion date | September 30, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Casa di cura riabilitativa Villa Sofia | Acireale | Catania |
Lead Sponsor | Collaborator |
---|---|
Nova Argentia S.r.l. |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | improvement in Clinical Healing score at visit 3 | improvement in Clinical Healing score at visit 3 | 30 days |
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