An international, observational retrospective data collection study assessing efficacy of applied risk minimisation measures in burn patients treated with NexoBrid (NexoPASS)

Study identification

• EU PAS number:
  EUPAS18751
• Study ID:
  31843
• Official title and acronym:
  An international, observational retrospective data collection study assessing efficacy of applied risk minimisation measures in burn patients treated with NexoBrid (NexoPASS)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Germany

  Poland

  Slovakia

  Spain

  Sweden
• Study description:
  The study will consist of a retrospective chart review performed in specialised centres in the EU using NexoBrid. It is planned to include about 160 patients. The main objective will be the comparison of incidence rates for pain and pyrexia with the incidence rates observed within the clinical trials after implementation of risk minimisation measures. The study will further assess the incidence of wound infections, compliance with the risk minimisation activities, time to wound closure and prescribing patterns such as the amount of patients treated off-label and other endpoints.
• Study status:
  Finalised

Research institutions and networks

Institutions

MediWound Ltd.

Multiple centres: 15 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual:14/03/2017

Study start date

Planned:01/07/2017

Actual:01/01/2018

Date of final study report

Planned:30/06/2019

Actual:12/09/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

MediWound LTD

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

Product reference: EMEA/H/C/002246Procedure number: MEA003.4