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NCT06284538: WOUND-H

Study to Evaluate the Effectiveness of a Medical Device Based on Hyaluronic Acid in Wounds

Status unknown NA Last updated 29 February 2024
What this trial tests

NA trial testing NOVA.EMOSTOP RE-EPITHELIZING in Wound Healing Disorder in 112 participants. Status unknown.

Timeline
15 January 2024
Primary endpoint
31 July 2024
30 September 2024

Quick facts

Lead sponsorNova Argentia S.r.l.
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposetreatment
Enrollment112
Start date15 January 2024
Primary completion31 July 2024
Estimated completion30 September 2024
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Nova Argentia S.r.l.

Who can join

18 and older, any sex, with Wound Healing Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06284538.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing