Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2026-02-26 @ 5:12 AM
Study NCT ID:
NCT02543034
Status:
COMPLETED
Last Update Posted:
2017-11-07
First Post:
2015-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compare of Petrolatum Gauze, Allevyn, and New Dressing, Betafoam® in the Management of Split-Thickness Skin Graft Donor Site
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-05', 'studyFirstSubmitDate': '2015-08-31', 'studyFirstSubmitQcDate': '2015-09-03', 'lastUpdatePostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy as measured by speed of wound healing', 'timeFrame': '6 months', 'description': 'Days needed for complete skin epithelialization in donor site wounds through routine swab culture (1 and 3 days) and visual assessment of wounds'}], 'secondaryOutcomes': [{'measure': 'Efficacy as measured by adverse event collection', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Skin Graft']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, controlled, multi-centre, open-label, phase IV study.\n\nTotal 81 patients will be enrolled in this study. Patients will be randomly assigned to Betafoam®, petrolatum gauze or Allevyn for donor site wounds after skin graft operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients who is same as or more than 19 years old\n2. Patients who will receive elective skin harvest operation\n3. Patients who is in lateral thigh or buttock with donor site area from 50 to 150 cm2\n4. Female patients who use method of contraception for the study\n5. Patients who voluntarily sign the informed consent\n\nExclusion Criteria:\n\n1. Patients who are pregnant\n2. Patients who are known to have allergy to the dressing product including PVPI\n3. Known hyperthyroidism or other thyroid dysfunction such as nodular thyroid goiter, endemic goiter and Hashimoto's thyroiditis or patients who receive radioiodine therapy\n4. Co-morbidities which may adversely affect wound healing for example a patient with uncontrolled diabetes (HbA1c \\> 8%), chronic renal failure, autoimmune disease, or immunocompromised patient\n5. Patients who receive anticoagulants, steroids or immunosuppressants\n6. Patients who have signs and symptoms of infection on enrollment and adversely affect wound healing\n7. Patients who have skin lesion such as Herpes zoster on donor site\n8. Burn of \\>20% total body surface area\n9. If the donor site had been harvested on a previous occasion\n10. Patients who is limited cognitive ability\n11. Patients who are participating in or will plan to participate in other clinical trials\n12. Other various conditions that the investigators judge inappropriate for enrolment"}, 'identificationModule': {'nctId': 'NCT02543034', 'briefTitle': 'Compare of Petrolatum Gauze, Allevyn, and New Dressing, Betafoam® in the Management of Split-Thickness Skin Graft Donor Site', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mundipharma Korea Ltd'}, 'officialTitle': 'Randomized, Controlled, Phase IV Study of Petrolatum Gauze, Allevyn, and New Dressing, Betafoam® in the Management of Split-Thickness Skin Graft Donor Site', 'orgStudyIdInfo': {'id': 'BTF14-KR-401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Betafoam Wound Dressing', 'description': "This contains 3% povidone iodine. Dressing will be routinely changed on day 3 and day 7, and can be replaced anytime due to various factors such as exudate control, dislodgement, or by investigators' clinical decision.", 'interventionNames': ['Device: Betafoam Wound Dressing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Petrolatum Gauze', 'description': "Dressing will be routinely changed on day 3 and day 7 and can be replaced anytime due to various factors such as exudate control, dislodgement, or by investigators' clinical decision.", 'interventionNames': ['Device: Petrolatum Gauze']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Allevyn Wound Dressing', 'description': "Allevyn adhesive wound dressing will be routinely changed on day 3 and day 7 and can be replaced anytime due to various factors such as exudate control, dislodgement, or by investigators' clinical decision.", 'interventionNames': ['Device: Allevyn Wound Dressing']}], 'interventions': [{'name': 'Betafoam Wound Dressing', 'type': 'DEVICE', 'otherNames': ['Betafoam'], 'description': 'Foam dressing including Betadine iodine', 'armGroupLabels': ['Betafoam Wound Dressing']}, {'name': 'Petrolatum Gauze', 'type': 'DEVICE', 'description': 'Gauze dressing', 'armGroupLabels': ['Petrolatum Gauze']}, {'name': 'Allevyn Wound Dressing', 'type': 'DEVICE', 'otherNames': ['Allevyn'], 'description': 'Foam dressing', 'armGroupLabels': ['Allevyn Wound Dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '137-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jongwon Lee, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St. Mary's Hospital, The Catholic University of Korea"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mundipharma Korea Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}