Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-03-01 @ 12:05 PM
Study NCT ID:
NCT01750034
Status:
WITHDRAWN
Last Update Posted:
2015-09-04
First Post:
2012-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Best Method of Burn Wound Care: A Prospective Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Malawi']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Feasibility issues', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-02', 'studyFirstSubmitDate': '2012-12-12', 'studyFirstSubmitQcDate': '2012-12-12', 'lastUpdatePostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Microbiologic profile of clinical infections', 'timeFrame': '30-day', 'description': 'Qualitative microbiologic culture results and sensitivity panels from surface swabs taken from infected burn wounds (as defined by clinical criteria described in the secondary outcome "burn wound infection rate").'}, {'measure': 'Number of surgical procedures', 'timeFrame': '30-day', 'description': 'Number of surgical procedures required including indication and type of procedure.'}, {'measure': 'percent skin graft survival', 'timeFrame': '30-day', 'description': 'Percent survival (defined as area surviving / total area grafted at 7 days) of skin grafts.'}, {'measure': 'Hospital length of stay', 'timeFrame': '30-day', 'description': 'Length of stay during initial hospitalization.'}], 'primaryOutcomes': [{'measure': 'Time to healing', 'timeFrame': '30-day', 'description': 'Time from burn injury to healing (defined as at least 90% epithelialization) as determined by hospital records, outpatient clinical records and telephone contact (with subject or next-of-kin) per study protocol.'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '30-day', 'description': 'Mortality within 30 days of burn injury, as determined by hospital records, outpatient clinical records and telephone contact (with next-of-kin) per study protocol.'}, {'measure': 'Burn wound infection rate', 'timeFrame': '30-day', 'description': 'Clinical suspicion of infection defined by presence of (a) burn wound cellulitis (erythema and/or edema AND pain and/or tenderness at the border of the wound), or (b) burn wound infection (change in appearance of the burn including focal or multifocal brown, black or violaceous discoloration OR rapid separation of the eschar OR conversion of partial thickness to full thickness burn).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Burns', 'Wounds and injuries', 'Bandages'], 'conditions': ['Burns']}, 'referencesModule': {'references': [{'pmid': '18226462', 'type': 'BACKGROUND', 'citation': 'Gosselin RA, Kuppers B. Open versus closed management of burn wounds in a low-income developing country. Burns. 2008 Aug;34(5):644-7. doi: 10.1016/j.burns.2007.09.013. Epub 2008 Jan 15.'}, {'pmid': '6074149', 'type': 'BACKGROUND', 'citation': 'Dominguez O, Bains JW, Lynch JB, Lewis SR. Treatment of burns with silver nitrate versus exposure method: analysis of 200 patients. Plast Reconstr Surg. 1967 Nov;40(5):489-93. doi: 10.1097/00006534-196711000-00012. No abstract available.'}, {'pmid': '13275898', 'type': 'BACKGROUND', 'citation': 'HOLMAN SP, SHAYA ES, HOFFMEISTER FS, EDGERTON MT Jr. Studies on burns. I. The exposure method vs. occlusive dressings in the local treatment of experimental burns. Ann Surg. 1956 Jan;143(1):49-56. doi: 10.1097/00000658-195601000-00006. No abstract available.'}, {'pmid': '23142508', 'type': 'BACKGROUND', 'citation': 'Kiser MM, Samuel JC, Mclean SE, Muyco AP, Cairns BA, Charles AG. Epidemiology of pediatric injury in Malawi: burden of disease and implications for prevention. Int J Surg. 2012;10(10):611-7. doi: 10.1016/j.ijsu.2012.10.004. Epub 2012 Nov 7.'}, {'pmid': '21819720', 'type': 'BACKGROUND', 'citation': 'Samuel JC, Campbell EL, Mjuweni S, Muyco AP, Cairns BA, Charles AG. The epidemiology, management, outcomes and areas for improvement of burn care in central Malawi: an observational study. J Int Med Res. 2011;39(3):873-9. doi: 10.1177/147323001103900321.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to better understand how to best care for burn wounds.', 'detailedDescription': 'Participants: Patients presenting to Kamuzu Central Hospital in Lilongwe Malawi with burn wounds occuring within 72 hours of admission.\n\nProcedures (methods): This is a prospective randomized trial. Subjects will be randomized during admission to receive either open dressing care or closed dressing care of their burn wounds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Burn wound admitted to the hospital\n* Signed informed consent\n* Burn wound occuring within 72 hours of admission\n\nExclusion Criteria:\n\n* Language other than Chichewa or English\n* Inability to access of phone (required for follow-up)'}, 'identificationModule': {'nctId': 'NCT01750034', 'briefTitle': 'Best Method of Burn Wound Care: A Prospective Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Best Method of Burn Wound Care: A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': '12-2288'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Closed method', 'description': 'Burn patients randomized to closed method of burn wound care.', 'interventionNames': ['Procedure: Closed method']}, {'type': 'EXPERIMENTAL', 'label': 'Open method', 'description': 'Burn patients randomized to the open method of burn wound care.', 'interventionNames': ['Procedure: Open method']}], 'interventions': [{'name': 'Closed method', 'type': 'PROCEDURE', 'otherNames': ['Bandage method', 'Dressing method'], 'description': 'Subjects will have their wounds managed by covering with gauze and changing this gauze 3 to 7 times per week.', 'armGroupLabels': ['Closed method']}, {'name': 'Open method', 'type': 'PROCEDURE', 'otherNames': ['Exposure method'], 'description': 'Subjects will have their burns managed by keeping the wounds exposed to the air.', 'armGroupLabels': ['Open method']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jared Gallaher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Chapel Hill Department of Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}