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

NCT ID: NCT03664505

Last Updated: 2019-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-06

Study Completion Date

2019-12-01

Brief Summary

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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

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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.

Conditions

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Burn Scar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
The patient receives two different burn garments and does not know which one was produced based on the scan data and which one on the manual measuring.

Study Groups

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Garment based on manual measurement

Garment based on manual measurement is used on burn scar

Group Type ACTIVE_COMPARATOR

Compression garment (manual)

Intervention Type DEVICE

Garment based on manual measurement

Garment based on scan measurement

Garment based on scan measurement is used on burn scar

Group Type EXPERIMENTAL

Compression garment (scan)

Intervention Type DEVICE

Garment based on scan measurement

Interventions

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Compression garment (manual)

Garment based on manual measurement

Intervention Type DEVICE

Compression garment (scan)

Garment based on scan measurement

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Schleswig-Holstein

OTHER

Sponsor Role lead

Responsible Party

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Tobias Kisch

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

Site Status

Countries

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Germany

Other Identifiers

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18-174

Identifier Type: -

Identifier Source: org_study_id

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