A prospective, non-interventional multicenter study, performed in patients with burns, to evaluate efficacy and safety aspects of NexoBrid in clinical practice

Study identification

• EU PAS number:
  EUPAS23046
• Study ID:
  29535
• Official title and acronym:
  A prospective, non-interventional multicenter study, performed in patients with burns, to evaluate efficacy and safety aspects of NexoBrid in clinical practice
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This study will be a prospective, non-interventional study, performed in patients with burns, to evaluate safety and efficacy aspects of NexoBrid in clinical practice. Documentation of the treatment outcomes will be performed by using the case report form as well as photographing the burns before and after application of NexoBrid.
• Study status:
  Finalised

Research institutions and networks

Institutions

Sana Klinikum Duisburg

BG Klinik Ludwigshafen Ludwig-Guttmann-Straße 13, 67071 Ludwigshafen/Rhein, Germany

Study timelines

Date when funding contract was signed

Actual:01/04/2014

Study start date

Actual:01/05/2014

Date of final study report

Planned:15/01/2019

Actual:15/01/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

MediWound Germany GmbH

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

OS-BURN2014