Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-12-31
2016-07-31
Brief Summary
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Specific Aim 2: To evaluate if one of three dressings provides greater functionality during and after healing of partial thickness hand burns.
Specific Aim 3: To determine if one of three burn dressings promotes aesthetically superior healing results for partial thickness hand burns.
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Detailed Description
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Given 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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Aquacel® Ag Burn Glove
Application of Aquacel® Ag Burn Glove burn dressing
Aquacel® Ag Burn Glove
burn dressing
Mepilex® Transfer Ag
Application of Mepilex® Transfer Ag burn dressing
Mepilex® Transfer Ag
burn dressing
Xeroform®/Bacitracin®
Application of Xeroform® burn dressing and Bacitracin® topical antibiotic
antibiotic
antibiotic burn dressing
Interventions
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Mepilex® Transfer Ag
burn dressing
antibiotic
antibiotic burn dressing
Aquacel® Ag Burn Glove
burn dressing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* \< 10% TBSA 2nd and 3rd degree burn injuries
* Initial clinical presentation \< 5 days post burn injury
Exclusion Criteria
* \> 10%TBSA burn injuries
* \> 60 years of age
* \< 8 years of age
* Patients (or parents of minors) without cognitive capacity to comprehend informed consent
* Presentation \> 5 days post-burn injury event
* Pregnant women
* Full thickness/3rd degree burns to the dorsal and/or palmer hand/s
* Exposed vital structures (tendons, nerves, bone, vessels)
* Uncontrolled Type II Diabetes
* Type I Diabetes
* History of Chronic Obstructive Pulmonary Disease
* Have a known allergy to silver products
* Signs of infection on initial clinical presentation (presence of purulent drainage, significant cellulitis, and/or fever)
* Smoke/inhalation injuries requiring ventilation
* Critically ill patients requiring intensive care
8 Years
60 Years
ALL
No
Sponsors
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Southern Illinois University
OTHER
Responsible Party
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Principal Investigators
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Nada N Berry, MD
Role: PRINCIPAL_INVESTIGATOR
Southern Illinois University
Locations
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Southern Illinois University School of Medicine
Springfield, Illinois, United States
Countries
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References
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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.
Robson MC, Smith DJ Jr, VanderZee AJ, Roberts L. Making the burned hand functional. Clin Plast Surg. 1992 Jul;19(3):663-71.
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.
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.
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.
Hollinger MA. Toxicological aspects of topical silver pharmaceuticals. Crit Rev Toxicol. 1996 May;26(3):255-60. doi: 10.3109/10408449609012524.
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.
Related Links
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Institute for Plastic Surgery, Office for Clinical Research
Other Identifiers
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ABR-SIUSOM-14-002
Identifier Type: -
Identifier Source: org_study_id
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