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Long Term (>30 months following wound closure) assessments of cosmesis, function and quality of life in pediatric subjects following participation in study MW2012-01-01 evaluating the efficacy and safety of NexoBrid as compared to standard of care (SOC) treatment

Long Term (>30 months following wound closure) assessments of cosmesis, function and quality of life in pediatric subjects following participation in study MW2012-01-01 evaluating the efficacy and safety of NexoBrid as compared to standard of care (SOC) treatment

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2022-001909-53-BE
Enrollment
9
Registered
2022-06-30
Start date
2022-10-24
Completion date
Unknown
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To evaluate and compare the cosmesis, function and QoL in children who had their target burn wounds eschar removed by NexoBrid or by SOC in study MW2012-01-01

Interventions

Trade Name: NexoBrid Product Name: NexoBrid Pharmaceutical Form: Powder and gel for gel

Sponsors

MediWound Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects who were treated for eschar removal in study MW2012-01-01. 2. Signed written informed consent by Patient or by a guardian, when applicable. Are the trial subjects under 18? yes Number of subjects for this age range: 7 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
Main Objective: The study objective is to evaluate and compare the cosmesis, function and QOL in children who had their target burn wounds eschar removed by NexoBrid or by SOC in study MW2012-01-01;Secondary Objective: Not applicable;Primary end point(s): Long Term (>30 months following wound closure) in pediatric subjects following participation in study MW2012-01-01;Timepoint(s) of evaluation of this end point: The duration of the study is one single visit for assessment of cosmesis, function and QoL at one time point—

Secondary

MeasureTime frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Long Term (>30 months following wound closure) in pediatric subjects following participation in study MW2012-01-01—

Countries

Belgium

Contacts

Public ContactGabriela Stara

GCP-Service International Ltd. & Co.KG

gstara@gcp-service.com004942189676635

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026