Study Stopped
Due to reorganization.
The Burn Glove Trial - Hand Burn Dressing Pilot
The Burn Glove Trial-A Randomized Controlled Trial of Dressings for Partial Thickness Hand Burns
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Specific Aim 1: To determine if one of three burn dressings provides a less painful healing experience for partial thickness hand. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2014
CompletedFirst Posted
Study publicly available on registry
December 17, 2014
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedJuly 21, 2016
July 1, 2016
7 months
July 23, 2014
July 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pain
pain as measured by the Patient and Provider Scar Assessment Scale
baseline to 6 months post-burn injury
Secondary Outcomes (6)
pain
baseline to 6 months post-burn injury
pain
baseline to 6 months post-burn injury
functionality
baseline to 6 months post-burn injury
functionality
baseline to 6 months post-burn injury
aesthetic appearance
baseline to 6 months post-burn injury
- +1 more secondary outcomes
Other Outcomes (2)
quality of life
baseline to 6 months post-burn injury
resilience
baseline to 6 months post-burn injury
Study Arms (3)
Aquacel® Ag Burn Glove
EXPERIMENTALApplication of Aquacel® Ag Burn Glove burn dressing
Mepilex® Transfer Ag
ACTIVE COMPARATORApplication of Mepilex® Transfer Ag burn dressing
Xeroform®/Bacitracin®
ACTIVE COMPARATORApplication of Xeroform® burn dressing and Bacitracin® topical antibiotic
Interventions
burn dressing
Eligibility Criteria
You may qualify if:
- Patients presenting at Memorial Medical or Southern Illinois University (SIU) Health Care
- 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
You may not qualify if:
- \< ½ % TBSA involving the hand
- \> 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southern Illinois University School of Medicine
Springfield, Illinois, 62794-9640, United States
Related Publications (7)
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: 18843629BACKGROUNDRobson MC, Smith DJ Jr, VanderZee AJ, Roberts L. Making the burned hand functional. Clin Plast Surg. 1992 Jul;19(3):663-71.
PMID: 1633673BACKGROUNDKamolz 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: 18952379BACKGROUNDWalburn 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: 19686881BACKGROUNDAtiyeh 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: 17137719BACKGROUNDHollinger MA. Toxicological aspects of topical silver pharmaceuticals. Crit Rev Toxicol. 1996 May;26(3):255-60. doi: 10.3109/10408449609012524.
PMID: 8726163BACKGROUNDBowler 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.
PMID: 15091147BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nada N Berry, MD
Southern Illinois University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2014
First Posted
December 17, 2014
Study Start
December 1, 2015
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
July 21, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share