Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-02-27 @ 4:32 PM
Study NCT ID:
NCT03664505
Status:
COMPLETED
Last Update Posted:
2019-12-03
First Post:
2018-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Product Properties of Individualized 3D-compression Garments to Treat Scars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011877', 'term': 'Radionuclide Imaging'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-01', 'studyFirstSubmitDate': '2018-08-31', 'studyFirstSubmitQcDate': '2018-09-06', 'lastUpdatePostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fitting of the garment (on a numeric rating scale 0-10)', 'timeFrame': '3 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Comfort of the garment (on a numeric rating scale 0-10)', 'timeFrame': '3 months', 'description': '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.'}, {'measure': 'Daily use of the garment (on a numeric rating scale 0-10)', 'timeFrame': '3 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Burn Scar']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Burn scars on an arm after IIa-III. burn (1-30% surface area)\n* Indication for burn garments\n* Experience in using burn garments\n\nExclusion Criteria:\n\n* Consume of pain killer\n* Medication with cortisone or immun suppressive therapy\n* Psychiatric disease'}, 'identificationModule': {'nctId': 'NCT03664505', 'briefTitle': 'Evaluation of the Product Properties of Individualized 3D-compression Garments to Treat Scars', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Schleswig-Holstein'}, 'officialTitle': 'Evaluation of the Product Properties of Individualized 3D-compression Garments to Treat Scars', 'orgStudyIdInfo': {'id': '18-174'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Garment based on manual measurement', 'description': 'Garment based on manual measurement is used on burn scar', 'interventionNames': ['Device: Compression garment (manual)']}, {'type': 'EXPERIMENTAL', 'label': 'Garment based on scan measurement', 'description': 'Garment based on scan measurement is used on burn scar', 'interventionNames': ['Device: Compression garment (scan)']}], 'interventions': [{'name': 'Compression garment (manual)', 'type': 'DEVICE', 'description': 'Garment based on manual measurement', 'armGroupLabels': ['Garment based on manual measurement']}, {'name': 'Compression garment (scan)', 'type': 'DEVICE', 'description': 'Garment based on scan measurement', 'armGroupLabels': ['Garment based on scan measurement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23538', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'University Hospital Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tobias Kisch', 'investigatorAffiliation': 'University Hospital Schleswig-Holstein'}}}}