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

University Hospital Schleswig-Holstein (UKSH)

Status: Completed

Conditions: Burn Scar

Treatments: Device: Compression garment (manual); Device: Compression garment (scan)

Study type: Interventional

Funder types: Other

Identifiers

NCT03664505

18-174

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Garment based on manual measurement

Active Comparator group

Description:

Garment based on manual measurement is used on burn scar

Treatment:

Device: Compression garment (manual)

Garment based on scan measurement

Experimental group

Description:

Garment based on scan measurement is used on burn scar

Treatment:

Device: Compression garment (scan)