Undersøgelse for at evaluere effektiviteten af et medicinsk udstyr baseret på hyaluronsyre i sår (WOUND-H)
Randomiseret kontrolleret undersøgelse til evaluering af ydeevnen og sikkerheden af en lineær hyaluronsyre-baseret medicinsk anordning til behandling af sår
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
Catania
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Acireale, Catania, Italien, 95024
- Casa di cura riabilitativa Villa Sofia
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 |
|
Aktiv komparator: Braccio controllo
NORMAL STANDARD THERAPIES FOR WOUND TREATMENT (CLEANING AND DISINFECTION) |
RE-EPITHELIZING GEL BASED ON HYALURONIC ACID |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
improvement in Clinical Healing score at visit 3
Tidsramme: 30 days
|
improvement in Clinical Healing score at visit 3 |
30 days
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Loredana Comito, Monitor, Clinical Research Consulting S.r.l.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- NA-01-23
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