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Evaluation of the Product Properties of Individualized 3D-compression Garments to Treat Scars

Evaluation of the Product Properties of Individualized 3D-compression Garments to Treat Scars

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03664505
Enrollment
10
Registered
2018-09-10
Start date
2018-09-06
Completion date
2019-12-01
Last updated
2019-12-03

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

Conditions

Burn Scar

Brief 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 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.

Interventions

DEVICECompression garment (manual)

Garment based on manual measurement

DEVICECompression garment (scan)

Garment based on scan measurement

Sponsors

University Hospital Schleswig-Holstein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

The patient receives two different burn garments and does not know which one was produced based on the scan data and which one on the manual measuring.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Burn scars on an arm after IIa-III. burn (1-30% surface area) * Indication for burn garments * Experience in using burn garments

Exclusion criteria

* Consume of pain killer * Medication with cortisone or immun suppressive therapy * Psychiatric disease

Design outcomes

Primary

MeasureTime frameDescription
Fitting of the garment (on a numeric rating scale 0-10)3 monthsNumeric 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.

Secondary

MeasureTime frameDescription
Comfort of the garment (on a numeric rating scale 0-10)3 monthsNumeric 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.
Daily use of the garment (on a numeric rating scale 0-10)3 monthsNumeric 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026