Onderzoek om de effectiviteit van een medisch hulpmiddel op basis van hyaluronzuur in wonden te evalueren (WOUND-H)
Gerandomiseerde gecontroleerde studie om de prestaties en veiligheid van een lineair op hyaluronzuur gebaseerd medisch hulpmiddel bij de behandeling van wonden te evalueren
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Catania
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Acireale, Catania, Italië, 95024
- Casa di cura riabilitativa Villa Sofia
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: WOUND-H
STUDY FOR THE ASSESSMENT OF THE EFFECTIVENESS OF A MEDICAL DEVICE BASED ON HYALURONIC ACID IN WOUNDS |
RE-EPITHELIZING GEL BASED ON HYALURONIC ACID |
|
Actieve vergelijker: Braccio controllo
NORMAL STANDARD THERAPIES FOR WOUND TREATMENT (CLEANING AND DISINFECTION) |
RE-EPITHELIZING GEL BASED ON HYALURONIC ACID |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
improvement in Clinical Healing score at visit 3
Tijdsspanne: 30 days
|
improvement in Clinical Healing score at visit 3 |
30 days
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Loredana Comito, Monitor, Clinical Research Consulting S.r.l.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- NA-01-23
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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