Burn ScarNCT03664505
Evaluation of the Product Properties of Individualized 3D-compression Garments to Treat Scars
A study testing Compression garment (manual) and Compression garment (scan) in people with Burn Scar, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
Burn scars are treated with compression garments. These are produced based on manual measure data. The aim of this study is to evaluate correct fitting, wearing comfort, suitability for daily use and scar properties after using garments produced on base of measuring data from scanning in comparison to manual measured… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Scar
- What is being tested?
- Compression garment (manual) and Compression garment (scan)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 6 Sep 2018to 1 Dec 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Burn scars on an arm after IIa-III. burn (1-30% surface area)
- Indication for burn garments
- Experience in using burn garments
Who cannot join
- Consume of pain killer
- Medication with cortisone or immun suppressive therapy
- Psychiatric disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
About this study
Burn scars are treated with compression garments. These are produced based on manual measure data. The aim of this study is to evaluate correct fitting, wearing comfort, suitability for daily use and scar properties after using garments produced on base of measuring data from scanning in comparison to manual measured data.
Read the detailed description
In plastic and reconstructive surgery, treatment of burn scars is still challenging, because excessive and hypertrophic scarring can occur. Burn garments are usually used to reduce such scarring. However, measure are taken manually by a measuring tape using interpolation. Therefore, compression garments produced on base of 3D surface imaging using a scanning system are compared to compression garments based on manually measurements regarding correct fitting, wearing comfort, suitability for daily use and scar properties.
- Conditions
- Burn Scar
- Being tested
- Compression garment (manual), Compression garment (scan)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression garment (manual)Device
Garment based on manual measurement
Compression garment (scan)Device
Garment based on scan measurement
| Study group | Role | What they receive |
|---|---|---|
| Garment based on manual measurement | Active comparator | Garment based on manual measurement is used on burn scar Receives: Device: Compression garment (manual) |
| Garment based on scan measurement | Experimental | Garment based on scan measurement is used on burn scar Receives: Device: Compression garment (scan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fitting of the garment (on a numeric rating scale 0-10)
Numeric rating scale from 0 (minimum) to 10 (maximum) judged by the patient: 0 means perfect fitting, 10 means no fitting). Higher values represent a worse outcome.
Measured: 3 months
Secondary outcomes (2)
Comfort of the garment (on a numeric rating scale 0-10)
Numeric rating scale from 0 (minimum) to 10 (maximum) judged by the patient: 0 means good wearing comfort, 10 means bad wearing comfort. Higher values represent a worse outcome.
Measured: 3 months
Daily use of the garment (on a numeric rating scale 0-10)
Numeric rating scale from 0 (minimum) to 10 (maximum) judged by the patient: 0 means good suitability of daily use, 10 means bad suitability of daily use. Higher values represent a worse outcome.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start6 Sep 2018
- Primary completion9 Nov 2018
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn ScarStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Kisch, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664505
- Sponsor's protocol ID
- 18-174
- Status last verified
- Dec 2019
- First submitted
- 31 Aug 2018
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Product Properties of Individualized 3D-compression Garments to Treat Scars
- ClinicalTrials.gov ID
- NCT03664505
- Acronym / sponsor ID
- 18-174
- Conditions
- Burn Scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- 9 Nov 2018 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 10 Sep 2018 (actual)
- 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.
Burn scars are treated with compression garments. These are produced based on manual measure data. The aim of this study is to evaluate correct fitting, wearing comfort, suitability for daily use and scar properties after using garments produced on base of measuring data from scanning in comparison to manual measured data.
Detailed description
In plastic and reconstructive surgery, treatment of burn scars is still challenging, because excessive and hypertrophic scarring can occur. Burn garments are usually used to reduce such scarring. However, measure are taken manually by a measuring tape using interpolation. Therefore, compression garments produced on base of 3D surface imaging using a scanning system are compared to compression garments based on manually measurements regarding correct fitting, wearing comfort, suitability for daily use and scar properties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Garment based on manual measurement | Active comparator | Device: Compression garment (manual)Garment based on manual measurement is used on burn scar |
| Garment based on scan measurement | Experimental | Device: Compression garment (scan)Garment based on scan measurement is used on burn scar |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Burn scars on an arm after IIa-III. burn (1-30% surface area)
- Indication for burn garments
- Experience in using burn garments
Key exclusion criteria (3 listed)
- Consume of pain killer
- Medication with cortisone or immun suppressive therapy
- Psychiatric disease
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 |
|---|---|---|
| Compression garment (manual)Garment based on manual measurement | Device | Garment based on manual measurement |
| Compression garment (scan)Garment based on scan measurement | Device | Garment based on scan measurement |
Primary outcome
Fitting of the garment (on a numeric rating scale 0-10)
Time frame: 3 months
Numeric rating scale from 0 (minimum) to 10 (maximum) judged by the patient: 0 means perfect fitting, 10 means no fitting). Higher values represent a worse outcome.
2 secondary outcomes
Comfort of the garment (on a numeric rating scale 0-10)
Time frame: 3 months
Daily use of the garment (on a numeric rating scale 0-10)
Time frame: 3 months
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 3 Dec 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression garment (manual) and Compression garment (scan) in people with Burn Scar, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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 3 inclusion and 3 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 3 Dec 2019. 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 Germany. 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?
Fitting of the garment (on a numeric rating scale 0-10) (time frame: 3 months). 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 3 Dec 2019.