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NexoBrid

A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns

Ensayo de MediWound Ltd. en quemaduras termicas.

Fase

Fase 3

Estado

Completado

Participantes

175

previstos

Centros

29

Fin del objetivo primario

jun 2018

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, simple ciego. Comenzó en may 2015.

Qué mide

Punto final primario: numero de participantes con extirpacion completa de la escara. (post application (post 2 h soaking)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study will be a three-arms study intending to demonstrate superiority of NexoBrid treatment over the Gel Vehicle placebo control treatment and over SOC in thermal burn subjects. The study objectives are: 1. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing complete eschar removal as compared with Gel vehicle, 2. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing earlier complete eschar removal, reduction in patients' surgical burden and its related blood loss as compared to SOC, 3. To assess the safety of NexoBrid compared to SOC, including demonstration that treatment with NexoBrid does not cause an unacceptable level of harm on wound closure outcome and long term outcomes of cosmesis and function.

Más ensayos de MDWD

Todos los de MDWD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02148705), actualizada en jul 2024.