Clinical trial NCT02318056: The Burn Glove Trial - Hand Burn Dressing Pilot
Official title: The Burn Glove Trial-A Randomized Controlled Trial of Dressings for Partial Thickness Hand Burns
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Burns
Keywords: hand
burns
thermal
dressing
Aquacel®
Mepilex® Transfer Ag
Xeroform®
Bacitracin®
partial thickness
epithelialization
wound healing
scar
scarring
Lead sponsor: Southern Illinois University
Sponsor class: OTHER
First posted: 2014-12-17
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Detailed description: 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* \< 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
* Critically ill patients requiring intensive care

Primary outcomes:
measure: pain
timeFrame: baseline to 6 months post-burn injury
Secondary outcomes:
measure: pain
timeFrame: baseline to 6 months post-burn injury
measure: pain
timeFrame: baseline to 6 months post-burn injury
measure: functionality
timeFrame: baseline to 6 months post-burn injury
measure: functionality
timeFrame: baseline to 6 months post-burn injury
measure: aesthetic appearance
timeFrame: baseline to 6 months post-burn injury
measure: aesthetic appearance
timeFrame: baseline to 6 months post-burn injury
Other outcomes:
measure: quality of life
timeFrame: baseline to 6 months post-burn injury
measure: resilience
timeFrame: baseline to 6 months post-burn injury
Locations:
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
Study officials:
affiliation: Southern Illinois University
name: Nada N Berry, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Robson MC, Smith DJ Jr, VanderZee AJ, Roberts L. Making the burned hand functional. Clin Plast Surg. 1992 Jul;19(3):663-71.
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.
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.
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.
citation: Hollinger MA. Toxicological aspects of topical silver pharmaceuticals. Crit Rev Toxicol. 1996 May;26(3):255-60. doi: 10.3109/10408449609012524.
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.