Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-03 @ 11:14 AM
Study NCT ID:
NCT02318056
Status:
WITHDRAWN
Last Update Posted:
2016-07-21
First Post:
2014-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Burn Glove Trial - Hand Burn Dressing Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000900', 'term': 'Anti-Bacterial Agents'}, {'id': 'D001414', 'term': 'Bacitracin'}, {'id': 'C004554', 'term': '2,4,6-tribromophenol'}], 'ancestors': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Due to reorganization.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-20', 'studyFirstSubmitDate': '2014-07-23', 'studyFirstSubmitQcDate': '2014-12-11', 'lastUpdatePostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'quality of life', 'timeFrame': 'baseline to 6 months post-burn injury', 'description': 'quality of life measured by the psychosocial scales: Burn Specific Health Scale (BSHS)'}, {'measure': 'resilience', 'timeFrame': 'baseline to 6 months post-burn injury', 'description': 'resilience measured by the Connor-Davidson Resilience Scale (CD-RISC)'}], 'primaryOutcomes': [{'measure': 'pain', 'timeFrame': 'baseline to 6 months post-burn injury', 'description': 'pain as measured by the Patient and Provider Scar Assessment Scale'}], 'secondaryOutcomes': [{'measure': 'pain', 'timeFrame': 'baseline to 6 months post-burn injury', 'description': 'pain as measured by the Michigan Hand Outcomes Questionnaire (MHQ)'}, {'measure': 'pain', 'timeFrame': 'baseline to 6 months post-burn injury', 'description': 'pain as measured by the Disabilities of the Arm, Shoulder and Hand Scale, Quick (QuickDASH)'}, {'measure': 'functionality', 'timeFrame': 'baseline to 6 months post-burn injury', 'description': 'functionality as measured by the Michigan Hand Outcomes Questionnaire (MHQ)'}, {'measure': 'functionality', 'timeFrame': 'baseline to 6 months post-burn injury', 'description': 'functionality as measured by the Disabilities of the Arm, Shoulder and Hand Scale, Quick (QuickDASH)'}, {'measure': 'aesthetic appearance', 'timeFrame': 'baseline to 6 months post-burn injury', 'description': 'scar formation and aesthetic appearance measured using the Vancouver Scar Scale'}, {'measure': 'aesthetic appearance', 'timeFrame': 'baseline to 6 months post-burn injury', 'description': 'scar formation and aesthetic appearance measured using the the Patient and Provider Scar Assessment Scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hand', 'burns', 'thermal', 'dressing', 'Aquacel®', 'Mepilex® Transfer Ag', 'Xeroform®', 'Bacitracin®', 'partial thickness', 'epithelialization', 'wound healing', 'scar', 'scarring'], 'conditions': ['Burns']}, 'referencesModule': {'references': [{'pmid': '18843629', 'type': 'BACKGROUND', 'citation': 'Wasiak J, Cleland H, Campbell F. Dressings for superficial and partial thickness burns. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD002106. doi: 10.1002/14651858.CD002106.pub3.'}, {'pmid': '1633673', 'type': 'BACKGROUND', 'citation': 'Robson MC, Smith DJ Jr, VanderZee AJ, Roberts L. Making the burned hand functional. Clin Plast Surg. 1992 Jul;19(3):663-71.'}, {'pmid': '18952379', 'type': 'BACKGROUND', 'citation': 'Kamolz LP, Kitzinger HB, Karle B, Frey M. The treatment of hand burns. Burns. 2009 May;35(3):327-37. doi: 10.1016/j.burns.2008.08.004. Epub 2008 Oct 25.'}, {'pmid': '19686881', 'type': 'BACKGROUND', 'citation': 'Walburn J, Vedhara K, Hankins M, Rixon L, Weinman J. Psychological stress and wound healing in humans: a systematic review and meta-analysis. J Psychosom Res. 2009 Sep;67(3):253-71. doi: 10.1016/j.jpsychores.2009.04.002. Epub 2009 Jul 2.'}, {'pmid': '17137719', 'type': 'BACKGROUND', 'citation': 'Atiyeh BS, Costagliola M, Hayek SN, Dibo SA. Effect of silver on burn wound infection control and healing: review of the literature. Burns. 2007 Mar;33(2):139-48. doi: 10.1016/j.burns.2006.06.010. Epub 2006 Nov 29.'}, {'pmid': '8726163', 'type': 'BACKGROUND', 'citation': 'Hollinger MA. Toxicological aspects of topical silver pharmaceuticals. Crit Rev Toxicol. 1996 May;26(3):255-60. doi: 10.3109/10408449609012524.'}, {'pmid': '15091147', 'type': 'BACKGROUND', 'citation': 'Bowler PG, Jones SA, Walker M, Parsons D. Microbicidal properties of a silver-containing hydrofiber dressing against a variety of burn wound pathogens. J Burn Care Rehabil. 2004 Mar-Apr;25(2):192-6. doi: 10.1097/01.bcr.0000112331.72232.1b.'}], 'seeAlsoLinks': [{'url': 'http://www.siumed.edu/surgery/plastics/clinical-research.html', 'label': 'Institute for Plastic Surgery, Office for Clinical Research'}]}, 'descriptionModule': {'briefSummary': 'Specific Aim 1: To determine if one of three burn dressings provides a less painful healing experience for partial thickness hand.\n\nSpecific Aim 2: To evaluate if one of three dressings provides greater functionality during and after healing of partial thickness hand burns.\n\nSpecific Aim 3: To determine if one of three burn dressings promotes aesthetically superior healing results for partial thickness hand burns.', 'detailedDescription': 'Various products are on the market and available for use on partial thickness burns to the hand/s. Our current institutional standard of care is to use Xeroform Gauze (Coviden, Mansfield, MA) and Bacitracin Ointment (Fougera, Melville, NY) to promote a moist antibacterial healing environment with the ability to monitor the healing progress daily. However, silver (AG) based dressings that employ nanocrystalline technology with hydrofiber (Aquacel AG burn; ConvaTec, Princeton, NJ) or soft silicone foam (Mepilex AG ; Molnlycke Health Care, Dunstable, United Kingdom) have been well accepted as alternative dressing solutions. These dressings have longer interval times between changes, leading to a reported increase in patient comfort, diminished skin shearing/stripping, and rapid re-epithelialization.\n\nGiven the anatomic intricacies, partial thickness burns to the hand present a challenge in dressing selection. Recently, ConvaTec unveiled the Aquacel AG Burn Glove for use on partial thickness hand burns. In line with this idea, our institution has now begun to fashion a novel burn glove out of Mepilex Transfer AG with good success. To date there are no known studies that compare Xeroform/Bacitracin, Aquacel AG burn glove or Mepilex Transfer AG dressing. The goal of this study is to compare these three burn dressings used to treat partial-thickness hand burns and their impact on pain, function, and aesthetic outcomes. We will also explore psychosocial issues related to hand burn dressing changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting at Memorial Medical or Southern Illinois University (SIU) Health Care\n* Patients with partial-thickness burn injuries to the dorsum and/or palm of the hand/s that exceeds ½% total body surface area (TBSA) for at least one hand.\n* \\< 10% TBSA 2nd and 3rd degree burn injuries\n* Initial clinical presentation \\< 5 days post burn injury\n\nExclusion Criteria:\n\n* \\< ½ % TBSA involving the hand\n* \\> 10%TBSA burn injuries\n* \\> 60 years of age\n* \\< 8 years of age\n* Patients (or parents of minors) without cognitive capacity to comprehend informed consent\n* Presentation \\> 5 days post-burn injury event\n* Pregnant women\n* Full thickness/3rd degree burns to the dorsal and/or palmer hand/s\n* Exposed vital structures (tendons, nerves, bone, vessels)\n* Uncontrolled Type II Diabetes\n* Type I Diabetes\n* History of Chronic Obstructive Pulmonary Disease\n* Have a known allergy to silver products\n* Signs of infection on initial clinical presentation (presence of purulent drainage, significant cellulitis, and/or fever)\n* Smoke/inhalation injuries requiring ventilation\n* Critically ill patients requiring intensive care'}, 'identificationModule': {'nctId': 'NCT02318056', 'briefTitle': 'The Burn Glove Trial - Hand Burn Dressing Pilot', 'organization': {'class': 'OTHER', 'fullName': 'Southern Illinois University'}, 'officialTitle': 'The Burn Glove Trial-A Randomized Controlled Trial of Dressings for Partial Thickness Hand Burns', 'orgStudyIdInfo': {'id': 'ABR-SIUSOM-14-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aquacel® Ag Burn Glove', 'description': 'Application of Aquacel® Ag Burn Glove burn dressing', 'interventionNames': ['Other: Aquacel® Ag Burn Glove']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mepilex® Transfer Ag', 'description': 'Application of Mepilex® Transfer Ag burn dressing', 'interventionNames': ['Other: Mepilex® Transfer Ag']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Xeroform®/Bacitracin®', 'description': 'Application of Xeroform® burn dressing and Bacitracin® topical antibiotic', 'interventionNames': ['Drug: antibiotic']}], 'interventions': [{'name': 'Aquacel® Ag Burn Glove', 'type': 'OTHER', 'otherNames': ['ConvaTec'], 'description': 'burn dressing', 'armGroupLabels': ['Aquacel® Ag Burn Glove']}, {'name': 'Mepilex® Transfer Ag', 'type': 'OTHER', 'otherNames': ['Safetac®', 'Molnlycke® Health Care'], 'description': 'burn dressing', 'armGroupLabels': ['Mepilex® Transfer Ag']}, {'name': 'antibiotic', 'type': 'DRUG', 'otherNames': ['Bacitracin®', 'Xeroform®'], 'description': 'antibiotic burn dressing', 'armGroupLabels': ['Xeroform®/Bacitracin®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62794-9640', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Southern Illinois University School of Medicine', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}], 'overallOfficials': [{'name': 'Nada N Berry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southern Illinois University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southern Illinois University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}