A Multicenter, Multinational, Randomized, Controlled, Assessor Blinded Study, Performed in Subjects With Thermal Burns, to Evaluate the Efficacy and Safety of NexoBrid Compared to Gel Vehicle and Compared to Standard of Care
Phase of Trial: Phase III
Latest Information Update: 09 Feb 2017
At a glance
- Drugs Bromelains (Primary) ; Collagenase
- Indications Burns
- Focus Therapeutic Use
- Acronyms DETECT
- Sponsors MediWound
- 09 Feb 2017 According to a MediWound media release, data from phase II (PK) study and PK data in large burns obtained from the ongoing DETECT study will intend to support a request to FDA and EMA to extend the label for NexoBrid (Bromelains) to larger burns.
- 14 Nov 2016 According to a MediWound media release, the acute top-line data is expected in the first half of 2018.
- 14 Nov 2016 According to a MediWound media release, the trial protocol has been amended to increase the Total Body Surface Area (TBSA) of burn patients eligible for the study from 15% to 30%.