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Completed

NCT Number: NCT03664505

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

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.

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Key information

Conditions

Burn Scar

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Compression garment (manual)

Device

Garment based on manual measurement

Compression garment (scan)

Device

Garment based on scan measurement

Primary outcomes

  1. 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.

Secondary outcomes

  1. Comfort 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 good wearing comfort, 10 means bad wearing comfort. Higher values represent a worse outcome.

  2. Daily use 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 good suitability of daily use, 10 means bad suitability of daily use. Higher values represent a worse outcome.

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Sep 10, 2018
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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