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

Not Applicable

Completed

• Conditions: Burn Scar
• Interventions: Device: Compression garment (manual); Device: Compression garment (scan)

• Registration Number: NCT03664505
• Lead Sponsor: University Hospital Schleswig-Holstein

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.

Study Timeline

• Study First Submitted: 2018-08-31
• Study Start: 2018-09-06
• Study First Submitted QC: 2018-09-06
• Study First Posted: 2018-09-10
• Primary Completion: 2018-11-09
• Status Verified: 2019-12
• Study Completion: 2019-12-01
• Last Update Submitted: 2019-12-01
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Garment based on manual measurement	Compression garment (manual)	Garment based on manual measurement is used on burn scar
Garment based on scan measurement	Compression garment (scan)	Garment based on scan measurement is used on burn scar

Primary Outcome Measures

Name	Time	Method
Fitting of the garment (on a numeric rating scale 0-10)	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 Outcome Measures

Name	Time	Method
Daily use of the garment (on a numeric rating scale 0-10)	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.
Comfort of the garment (on a numeric rating scale 0-10)	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.

Trial Locations

Locations (1)

University Hospital Schleswig-Holstein; 🇩🇪 Lübeck, Schleswig-Holstein, Germany