The Burn Glove Trial - Hand Burn Dressing Pilot
Status: | Withdrawn |
---|---|
Conditions: | Other Indications, Hospital |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 8 - 60 |
Updated: | 7/22/2016 |
Start Date: | December 2015 |
End Date: | July 2016 |
The Burn Glove Trial-A Randomized Controlled Trial of Dressings for Partial Thickness Hand Burns
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.
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.
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.
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.
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
We found this trial at
1
site
801 N Rutledge St
Springfield, Illinois 62702
Springfield, Illinois 62702
(217) 545-8000
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Principal Investigator: Nada N Berry, MD
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
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