Study to Evaluate the Effectiveness of a Medical Device Based on Hyaluronic Acid in Wounds

Launched by NOVA ARGENTIA S.R.L. · Feb 21, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new medical device made from hyaluronic acid to help improve the healing of post-surgical wounds. The main goal is to see how safe and effective this device is in helping wounds heal better over time. Researchers will measure how well the wounds are healing and whether patients experience any pain when changing the dressing. They will also keep track of any side effects that might occur during the study.

To participate in this study, you need to be an adult who has a post-surgical wound and can follow the study's instructions. Unfortunately, if you are pregnant, breastfeeding, or have certain medical conditions like allergies to study substances, or if you've recently participated in other clinical trials, you won't be eligible. If you decide to join, you can expect regular check-ins to assess your wound healing and to report any experiences you have with the device. This trial is currently recruiting participants, and your involvement could contribute to important findings in wound care.

Gender

ALL

Eligibility 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.