Long Term Follow up of Scars Formation and Quality of Life Assessment Study

NCT ID: NCT01350700

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

148 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-11-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In previous study (MW2004-011-02), patients with burn wounds had their damaged skin removed by either standard of care treatment or by Debrase Gel Dressing (DGD), which is composed of enzymes that dissolve the damaged skin selectively (DGD removes only the damaged skin and not other parts of the skin).

The burn wound, like any other wound, heals by the formation of scar at the injured site in order to replace the destroyed tissues. Scarring is not a static process, but rather a dynamic one, changing over time, especially during the first 24 months post-injury.

Scars and patients' quality of life from two treatment arms (DGD and SOC) will be compared in order to evaluate the long term influence of damaged skin removal and wound care techniques on scar formation and maturation.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Scars Formation Quality of Life

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

QOL

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients that were treated in MW2004-011-02 study with Debrase

Scars assessment & QOL

Intervention Type OTHER

Scar assessment and quality of life questionnaires

Patients that were treated in MW2004-011-02 with SOC

Scars assessment & QOL

Intervention Type OTHER

Scar assessment and quality of life questionnaires

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Scars assessment & QOL

Scar assessment and quality of life questionnaires

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Adults and children who had participated and completed study MW2004-11-02.
2. Subjects must be willing and able to sign a written informed consent prior to study entry (by subject or by a guardian, when applicable).
Minimum Eligible Age

4 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

MediWound Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bio-technology company, MediWound Ltd

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jan Koller, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Department Head of Burs and Reconstructive Surgery

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinic of Burns and reconstructive surgery hospital

Košice, , Slovakia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Slovakia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MW2012-01-02

Identifier Type: -

Identifier Source: org_study_id