- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT06284538
Studie för att utvärdera effektiviteten av en medicinsk anordning baserad på hyaluronsyra i sår (WOUND-H)
Randomiserad kontrollerad studie för att utvärdera prestanda och säkerhet hos en linjär hyaluronsyrabaserad medicinsk anordning vid behandling av 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Catania
-
Acireale, Catania, Italien, 95024
- Casa di cura riabilitativa Villa Sofia
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
improvement in Clinical Healing score at visit 3
Tidsram: 30 days
|
improvement in Clinical Healing score at visit 3 |
30 days
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Loredana Comito, Monitor, Clinical Research Consulting S.r.l.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- NA-01-23
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