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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: November 9, 2018

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

  • Device: Compression garment (manual)
    • Garment based on manual measurement
  • Device: Compression garment (scan)
    • Garment based on scan measurement

Arms, Groups and Cohorts

  • Active Comparator: Garment based on manual measurement
    • Garment based on manual measurement is used on burn scar
  • Experimental: Garment based on scan measurement
    • Garment based on scan measurement is used on burn scar

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Schleswig-Holstein
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tobias Kisch, Principal Investigator – University of Schleswig-Holstein

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