Wound Healing DisorderWOUND-HNCT06284538
Study to Evaluate the Effectiveness of a Medical Device Based on Hyaluronic Acid in Wounds
A study testing NOVA.EMOSTOP RE-EPITHELIZING in people with Wound Healing Disorder, run by Nova Argentia S.r.l. at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing Disorder
- What is being tested?
- NOVA.EMOSTOP RE-EPITHELIZING
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients with post-surgical wounds
- subjects capable of complying with the protocol procedures
- signing of informed consent
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Casa di cura riabilitativa Villa Sofia
Acireale, Catania, 95024
Marco Daniele, PI, 0957631997, marcodaniele@email.it
Salvatore Balsamo
About this study
Official 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.
Read the 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.
- Conditions
- Wound Healing Disorder
- Being tested
- NOVA.EMOSTOP RE-EPITHELIZING
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOVA.EMOSTOP RE-EPITHELIZINGDevice
RE-EPITHELIZING GEL BASED ON HYALURONIC ACID
| Study group | Role | What they receive |
|---|---|---|
| WOUND-H | Experimental | STUDY FOR THE ASSESSMENT OF THE EFFECTIVENESS OF A MEDICAL DEVICE BASED ON HYALURONIC ACID IN WOUNDS Receives: Device: NOVA.EMOSTOP RE-EPITHELIZING |
| Braccio controllo | Active comparator | NORMAL STANDARD THERAPIES FOR WOUND TREATMENT (CLEANING AND DISINFECTION) Receives: Device: NOVA.EMOSTOP RE-EPITHELIZING |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in Clinical Healing score at visit 3
improvement in Clinical Healing score at visit 3
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start15 Jan 2024
- Primary completion31 Jul 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Healing DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Argentia S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Loredana Comito, Monitor, Study chair, Clinical Research Consulting S.r.l.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284538
- Sponsor's protocol ID
- NA-01-23
- Acronym
- WOUND-H
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study to Evaluate the Performance and Safety of a Linear Hyaluronic Acid-based Medical Device in the Treatment of Wounds
- ClinicalTrials.gov ID
- NCT06284538
- Acronym / sponsor ID
- WOUND-H / NA-01-23
- Conditions
- Wound Healing Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Nova Argentia S.r.l.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WOUND-H | Experimental | Device: NOVA.EMOSTOP RE-EPITHELIZINGSTUDY FOR THE ASSESSMENT OF THE EFFECTIVENESS OF A MEDICAL DEVICE BASED ON HYALURONIC ACID IN WOUNDS |
| Braccio controllo | Active comparator | Device: NOVA.EMOSTOP RE-EPITHELIZINGNORMAL STANDARD THERAPIES FOR WOUND TREATMENT (CLEANING AND DISINFECTION) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients with post-surgical wounds
- subjects capable of complying with the protocol procedures
- signing of informed consent
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOVA.EMOSTOP RE-EPITHELIZINGRE-EPITHELIZING GEL BASED ON HYALURONIC ACID | Device | Braccio controllo, WOUND-H |
Primary outcome
improvement in Clinical Healing score at visit 3
Time frame: 30 days
improvement in Clinical Healing score at visit 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loredana Comito, Monitor study chair
Clinical Research Consulting S.r.l.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOVA.EMOSTOP RE-EPITHELIZING in people with Wound Healing Disorder, run by Nova Argentia S.r.l. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Daniele, PI (0957631997, marcodaniele@email.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in Clinical Healing score at visit 3 (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.