Study to Evaluate the Effectiveness of a Medical Device Based on Hyaluronic Acid in Wounds (WOUND-H)

February 21, 2024 updated by: Nova Argentia S.r.l.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Wound healing is a complex and dynamic process, which is still far from being fully understood. Wounds can be classified based on different characteristics such as the triggering factor, exposure to the external environment, depth of the wound, healing time period, potential risk of infections1. Two main processes are involved in wound healing: regeneration and repair. Regeneration involves the activation of stem cells capable of reconstituting the integrity of the tissue which will be indistinguishable from the tissue before the injury. Many strategies and products have been proposed in order to improve wound healing, reduce pain and morbidity for patients such as wound dressing, growth factors, skin substitutes, collagen dressing, topical insulin , the antioxidant, the hyperbaric chamber, etc. Hyaluronic acid (HA) was discovered in 1934 by Meyer and Palmer in bovine ocular vitreous. It is a naturally occurring glycosaminoglycan that, by virtue of its viscosity, elasticity and other rheological properties, acts as an ocular lubricant and as a lubricating and shock-absorbing fluid in the joints. It is produced by fibroblasts within the cell membrane and then released into the extracellular space. Inside the skin, it plays an important role in hydrating the extracellular space; constitutes a matrix to support the normal functions of cells; it also has functions in space filling, lubrication, wound healing, modulation of inflammatory cells, and scavenging of free radicals. Due to its remarkable biomedical and tissue regeneration potential, HA is widely used in the treatment of wounds under different formulations such as gauzes, creams and gels4, showing significant clinical results.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
    • Catania
      • Acireale, Catania, Italy, 95024
        • Recruiting
        • Casa di cura riabilitativa Villa Sofia
        • Contact:
        • Sub-Investigator:
          • Salvatore Balsamo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: WOUND-H
STUDY FOR THE ASSESSMENT OF THE EFFECTIVENESS OF A MEDICAL DEVICE BASED ON HYALURONIC ACID IN WOUNDS
Device: NOVA.EMOSTOP RE-EPITHELIZING
RE-EPITHELIZING GEL BASED ON HYALURONIC ACID
Active Comparator: Braccio controllo
NORMAL STANDARD THERAPIES FOR WOUND TREATMENT (CLEANING AND DISINFECTION)
Device: NOVA.EMOSTOP RE-EPITHELIZING
RE-EPITHELIZING GEL BASED ON HYALURONIC ACID

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
improvement in Clinical Healing score at visit 3
Time Frame: 30 days
improvement in Clinical Healing score at visit 3
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nova Argentia S.r.l.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Loredana Comito, Monitor, Clinical Research Consulting S.r.l.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 29, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NA-01-23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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