The Burn Glove Trial - Hand Burn Dressing Pilot

Not Applicable

Withdrawn

• Conditions: Burns
• Interventions: Other: Aquacel® Ag Burn Glove; Other: Mepilex® Transfer Ag; Drug: antibiotic

• Registration Number: NCT02318056
• Lead Sponsor: Southern Illinois University

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.

Study Timeline

• Study First Submitted: 2014-07-23
• Study First Submitted QC: 2014-12-11
• Study First Posted: 2014-12-17
• Study Start: 2015-12
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-20
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Aquacel® Ag Burn Glove	Aquacel® Ag Burn Glove	Application of Aquacel® Ag Burn Glove burn dressing
Mepilex® Transfer Ag	Mepilex® Transfer Ag	Application of Mepilex® Transfer Ag burn dressing
Xeroform®/Bacitracin®	antibiotic	Application of Xeroform® burn dressing and Bacitracin® topical antibiotic

Primary Outcome Measures

Name	Time	Method
pain	baseline to 6 months post-burn injury	pain as measured by the Patient and Provider Scar Assessment Scale

Secondary Outcome Measures

Name	Time	Method
functionality	baseline to 6 months post-burn injury	functionality as measured by the Disabilities of the Arm, Shoulder and Hand Scale, Quick (QuickDASH)
aesthetic appearance	baseline to 6 months post-burn injury	scar formation and aesthetic appearance measured using the the Patient and Provider Scar Assessment Scale
pain	baseline to 6 months post-burn injury	pain as measured by the Disabilities of the Arm, Shoulder and Hand Scale, Quick (QuickDASH)

Trial Locations

Locations (1)

Southern Illinois University School of Medicine; 🇺🇸 Springfield, Illinois, United States