Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-02-21 @ 7:01 PM
Study NCT ID:
NCT03627650
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2017-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fat Grafting in Skin-grafted Deep Burn Scars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'C564245', 'term': 'Platelet Glycoprotein IV Deficiency'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '2 skin zones per participant, A and B, 1 is treated, 1 is placebo coin toss determines which zone will be treated, this information is kept in sealed envelope'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomised controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-18', 'studyFirstSubmitDate': '2017-10-06', 'studyFirstSubmitQcDate': '2018-08-10', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of scar quality by histological assessment', 'timeFrame': '6 months', 'description': 'histology of scar tissue, scoring by 2 independent blinded anatomopathologists, (numerical scoring of fibroblast activity, collagen and elastin organisation, vascularity) scoring range min 1(close to normal tissue) - 3 (scar characteristics)'}, {'measure': 'improvement of scar quality by physiological testing with cutometer', 'timeFrame': '6 months, 1 year', 'description': 'measures elasticity of the scar; micrometer; higher values better outcome'}, {'measure': 'Improvement of scar quality by subjective evaluation with numerical Vancouver Scar Scale', 'timeFrame': '1 year', 'description': 'numerical score 0 to 13; ranges vascularity, height/thickness, pliability, and pigmentation'}, {'measure': 'Improvement of scar quality by subjective evaluation with numerical POSAS (Patient and Observer Scar Assessment Scale) Scale', 'timeFrame': '1 year', 'description': 'numerical score 5 to 50: VSS plus surface area; patient assessments of pain, itching, color, stiffness, thickness, relief'}, {'measure': 'improvement of scar quality by physiological testing with TEWA-meter (Trans Epidermal Water Loss-meter)', 'timeFrame': '6 months, 1 year', 'description': 'measures transepidermal water loss; g/m2/h; higher values worse outcome'}, {'measure': 'physiological testing of scar tissue by corneometer', 'timeFrame': '6 months, 1 year', 'description': 'measures hydration of the epidermis; corneometer units, higher values better outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['burn', 'scar', 'fat', 'grafting'], 'conditions': ['Burn Scar']}, 'descriptionModule': {'briefSummary': 'fat grafting in human skin-grafted immature burn scars histological, clinical and photographic follow-up', 'detailedDescription': 'Objective: A randomised clinical trial was performed to determine the effect of autologous fat grafting on scar formation in early skin-grafted deep burn wounds.\n\nMethods: Included patients received split-thickness skin grafting procedures for deep burn wounds less than 3 months ago. A homogenous scar area in each patient was divided into two equal parts. One part was treated with transcutaneous sharp needle autologous fat grafting, the adjacent part with transcutaneous saline injection as control. Results were evaluated by clinical assessment with scar scale questionnaires, histological examination, and objective scar assessment with Cutometer, Mexameter, Tewameter and Corneometer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* early skin-grafted deep burn scars\n* otherwise healthy\n\nExclusion Criteria:\n\n* concomitant disease'}, 'identificationModule': {'nctId': 'NCT03627650', 'briefTitle': 'Fat Grafting in Skin-grafted Deep Burn Scars', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Fat Grafting in Immature Skin-grafted Burn Scars: a Randomised Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'EC 2010/ 572'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 group of 15 patients', 'description': 'procedure/surgery: fat grafting injection of scar', 'interventionNames': ['Procedure: lipofilling/ fat grafting']}, {'type': 'EXPERIMENTAL', 'label': 'Same group of 15 patients', 'description': 'procedure/surgery: placebo injection of scar', 'interventionNames': ['Procedure: placebo injection']}], 'interventions': [{'name': 'lipofilling/ fat grafting', 'type': 'PROCEDURE', 'description': 'liposuction, processing/ cleaning of fat tissue; reinjection with sharp needle transcutaneous', 'armGroupLabels': ['1 group of 15 patients']}, {'name': 'placebo injection', 'type': 'PROCEDURE', 'armGroupLabels': ['Same group of 15 patients']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Maarten AJ Doornaert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UGent University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor, Head of Plastic Surgery, Principal Investigator', 'investigatorFullName': 'Phillip Blondeel', 'investigatorAffiliation': 'University Hospital, Ghent'}}}}