Scars FormationNCT01350700
Long Term Follow up of Scars Formation and Quality of Life Assessment Study
An observational study of Scars Formation and Quality of Life, run by MediWound Ltd at 1 site in Slovakia.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 4 to 55 years
- Conditions the study is for
- Scars Formation, Quality of Life
- What is being tested?
- Scars assessment & QOL
- How many people
- 148 participants
- Where
- 1 siteSlovakia
- Study dates
- Jun 2011to 22 Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients that have previously participated in MW2004-011-02 study
Who may be able to join
- Adults and children who had participated and completed study MW2004-11-02.
- Subjects must be willing and able to sign a written informed consent prior to study entry (by subject or by a guardian, when applicable).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scar Formation and Quality of Life Assessment in Subjects (Adults & Children) Following Treatment With Debrase Compared to Standard of Care (SOC)
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.
- Conditions
- Scars Formation, Quality of Life
- Being tested
- Scars assessment & QOL
- Keywords
- QOL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scars assessment & QOLOther
Scar assessment and quality of life questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Patients that were treated in MW2004-011-02 study with Debrase | Not described Receives: Other: Scars assessment & QOL | |
| Patients that were treated in MW2004-011-02 with SOC | Not described Receives: Other: Scars assessment & QOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Scar assessment of target wounds that have been treated by Debrase or SOC during MW2004-11-02 using Modified Vancouver Scar Scale (MVSS)
Assesment of scars will be done using the Modified Vancouver Scar Scale
Measured: Approximately 2 years after wound closure
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
- A Quality of Life (QoL) assessment will be performed in burn victims using a Short Form 36 (SF-36) and Burn Outcomes Questionnaire (BOQ).
Measured: Approximately 2 years after wound closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2011
- Study completion22 Nov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scars FormationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediWound Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jan Koller, MD,PhD, Principal investigator, Department Head of Burs and Reconstructive Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350700
- Sponsor's protocol ID
- MW2012-01-02
- Status last verified
- May 2011
- First submitted
- 8 May 2011
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scar Formation and Quality of Life Assessment in Subjects (Adults & Children) Following Treatment With Debrase Compared to Standard of Care (SOC)
- ClinicalTrials.gov ID
- NCT01350700
- Acronym / sponsor ID
- MW2012-01-02
- Conditions
- Scars Formation, Quality of Life
- Keywords
- QOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- MediWound LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- 22 Nov 2011 (actual)
- First posted
- 10 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients that were treated in MW2004-011-02 study with Debrase | – | Other: Scars assessment & QOL |
| Patients that were treated in MW2004-011-02 with SOC | – | Other: Scars assessment & QOL |
Who may qualify
- Ages
- 4 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients that have previously participated in MW2004-011-02 study
Key inclusion criteria (2 listed)
- Adults and children who had participated and completed study MW2004-11-02.
- Subjects must be willing and able to sign a written informed consent prior to study entry (by subject or by a guardian, when applicable).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scars assessment & QOLScar assessment and quality of life questionnaires | Other | Patients that were treated in MW2004-011-02 study with Debrase, Patients that were treated in MW2004-011-02 with SOC |
Primary outcome
1. Scar assessment of target wounds that have been treated by Debrase or SOC during MW2004-11-02 using Modified Vancouver Scar Scale (MVSS)
Time frame: Approximately 2 years after wound closure
Assesment of scars will be done using the Modified Vancouver Scar Scale
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
Time frame: Approximately 2 years after wound closure
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Koller, MD,PhD principal investigator
Department Head of Burs and Reconstructive Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scars Formation and Quality of Life, run by MediWound Ltd at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Scar assessment of target wounds that have been treated by Debrase or SOC during MW2004-11-02 using Modified Vancouver Scar Scale (MVSS) (time frame: Approximately 2 years after wound closure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.