Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-01-04 @ 3:56 PM
Study NCT ID:
NCT02373566
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2015-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy of an Acellular Dermal Template for the Treatment of Full Thickness Skin Defects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'participant and assessor are both unaware of location of dermal template'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'part of wound treated with /without dermal template'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2015-02-23', 'studyFirstSubmitQcDate': '2015-02-26', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scar quality as assessed for scar elasticity (experimental vs control area) as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS)', 'timeFrame': '3 months post-operative', 'description': 'Scar elasticity as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS)'}], 'secondaryOutcomes': [{'measure': 'Graft take (Subjective assessment by experienced observer)', 'timeFrame': '5-7 days'}, {'measure': 'Epithelialisation (Subjective assessment by experienced observer)', 'timeFrame': '5-7 days and 2-3 weeks post-operative', 'description': 'Subjective assessment by experienced observer'}, {'measure': 'Scar quality (Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire)', 'timeFrame': '12 months', 'description': 'Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire'}, {'measure': 'Scar quality (As determined with subjective scar assessment scale (POSAS)', 'timeFrame': '3 and 12 months', 'description': 'As determined with subjective scar assessment scale (POSAS)'}, {'measure': 'Scar quality (As measured for scar colour and pigmentation using DSM II ColorMeter)', 'timeFrame': '3 and 12 months', 'description': 'As measured for scar colour and pigmentation using DSM II ColorMeter'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['burns', 'dermal substitute', 'scar quality', 'reconstruction', 'wound healing', 'wound closure'], 'conditions': ['Full Thickness Skin Defects']}, 'referencesModule': {'references': [{'pmid': '24178984', 'type': 'BACKGROUND', 'citation': 'Boekema BK, Vlig M, Olde Damink L, Middelkoop E, Eummelen L, Buhren AV, Ulrich MM. Effect of pore size and cross-linking of a novel collagen-elastin dermal substitute on wound healing. J Mater Sci Mater Med. 2014 Feb;25(2):423-33. doi: 10.1007/s10856-013-5075-2. Epub 2013 Nov 1.'}], 'seeAlsoLinks': [{'url': 'https://cordis.europa.eu/article/rcn/125139/it', 'label': 'euroskingraft results'}]}, 'descriptionModule': {'briefSummary': 'In this study the efficacy of an acellular dermal template (Novomaix), combined with split thickness skin grafts, for use in patients with full thickness skin defects, is tested. Results will be compared intra-patient with those obtained after conventional treatment with split thickness skin grafts. The investigators expect this treatment to provide better outcome regarding scar quality.', 'detailedDescription': 'Using dermal substitutes in combination with a split-thickness skin graft (STSG) is a well acknowledged therapy in burns and reconstructive surgery. Nevertheless, the ideal substitute is not available yet. We therefore want to investigate the use of an acellular dermal template (Novomaix), in combination with STSG, to treat these defects. Patients with with full thickness skin defects will be included in this study. This phase II study aims to investigate the efficacy of the use of this dermal matrix, with regard to scar quality as determined for elasticity at 3 months after treatment. Moreover, graft take (5-7 days after treatment), epithelialisation (5-7 days and 2-3 weeks), and scar quality (3 and 12 months after treatment, as determined for elasticity, colour/pigmentation, and using a subjective scar assessment scale) will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years (for Zurich: ≤ 18 years)\n* Full thickness skin defects configured in such a way that two comparable and measurable areas can be grafted, both of minimally 3x3 cm\n* ≤ 50% TBSA full thickness skin defects at time of intervention\n* Informed consent by the patient and/or legal representatives.\n\nExclusion Criteria:\n\n* Patients with infected wounds\n* Full thickness skin wounds located in face and/or genitals will not be included\n* Pregnant or breast feeding females\n* Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, uncontrolled diabetes, treatment with corticoid therapy, collagenoses, cancer)\n* Known allergy against porcine collagen or elastin\n* Patients that are expected (according to the responsible medical doctor) to be non-compliant to the study protocol. (This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)\n* Previous enrolment of the patient into the current study'}, 'identificationModule': {'nctId': 'NCT02373566', 'briefTitle': 'A Study to Evaluate the Efficacy of an Acellular Dermal Template for the Treatment of Full Thickness Skin Defects', 'organization': {'class': 'OTHER', 'fullName': 'Association of Dutch Burn Centres'}, 'officialTitle': 'A Phase 2, Intra-patient Randomised Controlled Multicentre International Study to Evaluate the Efficacy of an Acellular Dermal Template Novomaix for the Treatment of Full Thickness Skin Defects', 'orgStudyIdInfo': {'id': 'ESG-NVM-II-2014'}, 'secondaryIdInfos': [{'id': 'NL50542.094.14', 'type': 'OTHER', 'domain': 'ABR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dermal substitute with STSG', 'description': 'Novomaix dermal substitute in combination with STSG', 'interventionNames': ['Device: Novomaix dermal substitute in combination with STSG']}, {'type': 'NO_INTERVENTION', 'label': 'STSG alone', 'description': 'STSG alone'}], 'interventions': [{'name': 'Novomaix dermal substitute in combination with STSG', 'type': 'DEVICE', 'otherNames': ['Novomaix'], 'description': 'Novomaix dermal substitute in combination with STSG', 'armGroupLabels': ['Dermal substitute with STSG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12683', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '1942 LE', 'city': 'Beverwijk', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Red Cross Hospital', 'geoPoint': {'lat': 52.48333, 'lon': 4.65694}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': "Children's Hospital Department of Surgery Kinderspital Zurich", 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Esther Middelkoop, Prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Red Cross Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association of Dutch Burn Centres', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ernst Reichmann Tissue Biology Research Unit, Zürich', 'class': 'OTHER'}, {'name': 'Seventh Framework Programme', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}