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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Burn Scar

Intervention / Treatment
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* Device: Compression garment (manual)
* Device: Compression garment (scan)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Garment based on manual measurement<br>Garment based on manual measurement is used on burn scar | Device: Compression garment (manual)<br>* Garment based on manual measurement<br>|
| Experimental: Garment based on scan measurement<br>Garment based on scan measurement is used on burn scar | Device: Compression garment (scan)<br>* Garment based on scan measurement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 3 months |