The Burn Glove Trial - Hand Burn Dressing Pilot

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Burn Glove Trial-A Randomized Controlled Trial of Dressings for Partial Thickness Hand Burns

Conditions
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Burns

Intervention / Treatment
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* Other: Aquacel® Ag Burn Glove
* Other: Mepilex® Transfer Ag
* Drug: antibiotic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aquacel® Ag Burn Glove<br>Application of Aquacel® Ag Burn Glove burn dressing | Other: Aquacel® Ag Burn Glove<br>* burn dressing<br>* Other names: ConvaTec;|
| Active Comparator: Mepilex® Transfer Ag<br>Application of Mepilex® Transfer Ag burn dressing | Other: Mepilex® Transfer Ag<br>* burn dressing<br>* Other names: Molnlycke® Health Care;|
| Active Comparator: Xeroform®/Bacitracin®<br>Application of Xeroform® burn dressing and Bacitracin® topical antibiotic | Drug: antibiotic<br>* antibiotic burn dressing<br>* Other names: Xeroform®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | pain as measured by the Patient and Provider Scar Assessment Scale | baseline to 6 months post-burn injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | pain as measured by the Michigan Hand Outcomes Questionnaire (MHQ) | baseline to 6 months post-burn injury | 
| pain | pain as measured by the Disabilities of the Arm, Shoulder and Hand Scale, Quick (QuickDASH) | baseline to 6 months post-burn injury | 
| functionality | functionality as measured by the Michigan Hand Outcomes Questionnaire (MHQ) | baseline to 6 months post-burn injury | 
| functionality | functionality as measured by the Disabilities of the Arm, Shoulder and Hand Scale, Quick (QuickDASH) | baseline to 6 months post-burn injury | 
| aesthetic appearance | scar formation and aesthetic appearance measured using the Vancouver Scar Scale | baseline to 6 months post-burn injury | 
| aesthetic appearance | scar formation and aesthetic appearance measured using the the Patient and Provider Scar Assessment Scale | baseline to 6 months post-burn injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hand, burns, thermal, dressing, Aquacel®, Mepilex® Transfer Ag, Xeroform®, Bacitracin®, partial thickness, epithelialization, wound healing, scar, scarring