Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-30 @ 4:36 AM
Study NCT ID:
NCT01704950
Status:
COMPLETED
Last Update Posted:
2016-02-25
First Post:
2012-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcome of Defect Reconstruction Using IDRT Single Layer : Results From a Prospective Multicentric Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-24', 'studyFirstSubmitDate': '2012-10-09', 'studyFirstSubmitQcDate': '2012-10-09', 'lastUpdatePostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of graft take', 'timeFrame': 'Day 15 after the surgery', 'description': 'the mean percentage of healing expected at Day 15 after the surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Traumatic Wound', 'Reconstruction Wound']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to provide data and the guidelines for the use of IDRT SL in small wounds, acute and chronic (less than 6 months), showing the benefits and the easy to use of this product as a one stage procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Global population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patient with 1 traumatic wound (burns included) or 1 reconstruction wound (oncological wounds included)\n* Patients for whom the surgeon has recommended that an INTEGRA® SL matrix be implanted (even if the patient is not taking part in the study) with a Split Thickness Skin Graft in the same operating procedure\n* Wound treated with only one layer of a maximum size 10cm\\*12.5cm\n\nExclusion Criteria:\n\n* Immunosuppressed patient\n* Chronic wound (with no healing since 6 months)\n* Addition of any substances (growth factor, stem cells,…) in the IDRT SL during the surgery\n* Patient with a corticoid treatment with a daily dose greater than 5 mg\n* Patients whose life expectancy is less than 12 months\n* Patients whose mental health or health condition (Visual deficiency, Alzheimers…) would compromise completion of the self-evaluation questionnaires\n* Patient with an hypersensitivity to bovine collagen, chondroitin\n* Patient with clinical signs of infection (fever, pain, colour, swelling,…) and for whom the investigator diagnosed infection'}, 'identificationModule': {'nctId': 'NCT01704950', 'briefTitle': 'Clinical Outcome of Defect Reconstruction Using IDRT Single Layer : Results From a Prospective Multicentric Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integra LifeSciences Services'}, 'officialTitle': 'Clinical Outcome of Defect Reconstruction Using IDRT Single Layer : Results From a Prospective Multicentric Trial', 'orgStudyIdInfo': {'id': 'RECON-EMEA-11'}}, 'contactsLocationsModule': {'locations': [{'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'St Josef Hospital', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'General State Hospital of Athens, "G. Gennimatas" - Department of Plastic Surgery-Microsurgery and Burn Center', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '33100', 'city': 'Udine', 'country': 'Italy', 'facility': 'University Hospital "S. Maria della Misericordia" - Plastic Surgery and Burn Center', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'zip': 'B15 2WB', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital - Burn and Plastic Surgery', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'overallOfficials': [{'name': 'Stefanos Papadopoulos', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General State Hospital of Athens, "G. Gennimatas"'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integra LifeSciences Services', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}