Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03664505
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Tobias Kisch, University of 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.

Condition or disease Intervention/treatment Phase
Burn Scar Device: Compression garment (manual) Device: Compression garment (scan) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Evaluation of the Product Properties of Individualized 3D-compression Garments to Treat Scars
Actual Study Start Date : September 6, 2018
Estimated Primary Completion Date : November 9, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Garment based on manual measurement
Garment based on manual measurement is used on burn scar
Device: Compression garment (manual)
Garment based on manual measurement

Experimental: Garment based on scan measurement
Garment based on scan measurement is used on burn scar
Device: Compression garment (scan)
Garment based on scan measurement




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664505


Locations
Layout table for location information
Germany
University Hospital Schleswig-Holstein Recruiting
Lübeck, Schleswig-Holstein, Germany, 23538
Contact: Tobias Kisch, MD    004945150040512    tobias.kisch@uksh.de   
Sponsors and Collaborators
University of Schleswig-Holstein

Layout table for additonal information
Responsible Party: Tobias Kisch, Principal Investigator, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT03664505     History of Changes
Other Study ID Numbers: 18-174
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No