Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-28 @ 5:57 PM
Study NCT ID:
NCT00600457
Status:
COMPLETED
Last Update Posted:
2008-12-16
First Post:
2008-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modified Polyurethane Film Dressing For Skin Graft Donor Sites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-15', 'studyFirstSubmitDate': '2008-01-23', 'studyFirstSubmitQcDate': '2008-01-23', 'lastUpdatePostDateStruct': {'date': '2008-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'uncontrolled leakage', 'timeFrame': '1-10th day postoperative'}], 'secondaryOutcomes': [{'measure': 'pain', 'timeFrame': '1-10th day postoperative'}, {'measure': 'infection', 'timeFrame': '1-10th day postoperative'}, {'measure': 'epithelization status', 'timeFrame': '10th day postoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['healing time', 'pain', 'infection'], 'conditions': ['Wound Healing']}, 'referencesModule': {'references': [{'pmid': '396845', 'type': 'BACKGROUND', 'citation': 'Birdsell DC, Hein KS, Lindsay RL. The theoretically ideal donor site dressing. Ann Plast Surg. 1979 Jun;2(6):535-7. doi: 10.1097/00000637-197906000-00015.'}, {'pmid': '1098708', 'type': 'BACKGROUND', 'citation': 'James JH, Watson AC. The use of Opsite, a vapour permeable dressing, on skin graft donor sites. Br J Plast Surg. 1975 Apr;28(2):107-10.'}, {'pmid': '6701224', 'type': 'BACKGROUND', 'citation': 'Ramirez OM, Granick MS, Futrell JW. Optimal wound healing under Op-Site dressing. Plast Reconstr Surg. 1984 Mar;73(3):474-5. doi: 10.1097/00006534-198403000-00028.'}, {'pmid': '15269581', 'type': 'BACKGROUND', 'citation': 'Barnea Y, Amir A, Leshem D, Zaretski A, Weiss J, Shafir R, Gur E. Clinical comparative study of aquacel and paraffin gauze dressing for split-skin donor site treatment. Ann Plast Surg. 2004 Aug;53(2):132-6. doi: 10.1097/01.sap.0000112349.42549.b3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the combination of modified polyurethane film and secondary absorbent dressing for skin graft donor sites avoids the regular uncontrolled leakage, but holds up the advantages of film dressings for this kind of wound.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults over age 18 who require skin grafting\n\nExclusion Criteria:\n\n* Individuals under the age of 18.'}, 'identificationModule': {'nctId': 'NCT00600457', 'briefTitle': 'Modified Polyurethane Film Dressing For Skin Graft Donor Sites', 'organization': {'class': 'OTHER', 'fullName': 'Klinik Bogenhausen'}, 'officialTitle': 'Modified Polyurethane Film Dressing For Skin Graft Donor Sites', 'orgStudyIdInfo': {'id': 'MOPS-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A,1', 'interventionNames': ['Device: Polyurethane Film']}], 'interventions': [{'name': 'Polyurethane Film', 'type': 'DEVICE', 'description': 'The modified polyurethane film is combined with a secondary absorbent dressing and remained intact until the 10th postoperative day', 'armGroupLabels': ['A,1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Munich', 'country': 'Germany', 'facility': 'Department of Plastic, Reconstructive, Hand and Burn Surgery, Academic Hospital Munich Bogenhausen, Technical University Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Ulf Dornseifer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Plastic, Reconstructive, Hand and Burn Surgery, Academic Hospital Munich-Bogenhausen, Technical University Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinik Bogenhausen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ulf Dornseifer, MD', 'oldOrganization': 'Department of Plastic Surgery, Academic Hospital Munich-Bogenhausen, Technical University Munich'}}}}