Long Term Follow Up Of Scars For Patients That Participated In Study MW2004-11-02, As Well Assessment Of Quality Of Life

Scar Formation and Quality of Life assessment in subjects (adults & children) following treatment with Debrase compared to Standard of Care (SOC)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001889-17-GB

Enrollment

148

Registered

2011-05-13

Start date

2011-07-26

Completion date

Unknown

Last updated

2012-08-28

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

Conditions

long term scar formation MedDRA version: 13.1 Level: LLT Classification code 10057061 Term: Burn scar System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Product Name: Debrase gel Dressing Product Code: Debrase gel Dressing Pharmaceutical Form: Gel INN or Proposed INN: Debrase powder Concentration unit: g gram(s) Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults and children who had participated and completed study MW2004-11-02. 2. Subjects must be able to sign and dated written informed consent prior to study entry (by subject or by a guardian, when applicable). Are the trial subjects under 18? yes Number of subjects for this age range: 26 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 122 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Adults and children who did NOT participate and complete study MW2004-11-02. 2. Subjects NOT willing and able to sign a written informed consent prior to study entry (by subject or by a guardian, when applicable).

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To evaluate and compare the long term scar formation in adult and children who had their target burn wounds eschar removed by enzymatic debriding agent, Debrase or by Standard Of Care (SOC) in study MW2004-11-02. 2. To evaluate and compare the Quality of Life (QoL) in adult and children that their burn wounds were treated with Debrase or SOC in study MW2004-11-02. ;Secondary Objective: No;Primary end point(s): 1. Scar assessment of target wounds that have been treated by Debrase or SOC during MW2004-11-02 using Modified Vancouver Scar Scale (MVSS). Scar scores will be calculated based on MVSS and comparison will be performed between the Debrase and the SOC as detailed in the SAP. 2. A Quality of Life (QoL) assessment will be performed in burn victims using a Short Form 36 (SF-36) and Burn Outcomes Questionnaire (BOQ). In SF-36, Scale scores will be calculated based on known scales (scales ranging 0-100) and comparison will be performed between the Debrase and the SOC as detailed in the SAP. ;Timepoint(s) of evaluation of this end point: Subjects that will agree to participate in the study will be invited to the clinic for a one day visit for assessments.	—

Measure

Time frame

Main Objective: 1. To evaluate and compare the long term scar formation in adult and children who had their target burn wounds eschar removed by enzymatic debriding agent, Debrase or by Standard Of Care (SOC) in study MW2004-11-02. 2. To evaluate and compare the Quality of Life (QoL) in adult and children that their burn wounds were treated with Debrase or SOC in study MW2004-11-02. ;Secondary Objective: No;Primary end point(s): 1. Scar assessment of target wounds that have been treated by Debrase or SOC during MW2004-11-02 using Modified Vancouver Scar Scale (MVSS). Scar scores will be calculated based on MVSS and comparison will be performed between the Debrase and the SOC as detailed in the SAP. 2. A Quality of Life (QoL) assessment will be performed in burn victims using a Short Form 36 (SF-36) and Burn Outcomes Questionnaire (BOQ). In SF-36, Scale scores will be calculated based on known scales (scales ranging 0-100) and comparison will be performed between the Debrase and the SOC as detailed in the SAP. ;Timepoint(s) of evaluation of this end point: Subjects that will agree to participate in the study will be invited to the clinic for a one day visit for assessments.

—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Australia, Brazil, France, Germany, India, Israel, Poland, Romania, Slovakia, United Kingdom

Contacts

Public ContactClinical Trial Information Desk

Teva Pharma GmbH

info.era-clinical@teva.de00000000000

Outcome results

None listed

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