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

Burn Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03664505
• Other study ID #: 18-174
• Status: Completed
• Phase: N/A
• Start date: September 6, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2019
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 1, 2019
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burn Scar
• Cicatrix

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Schleswig-Holstein	Lübeck	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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