The Burn Glove Trial - Hand Burn Dressing Pilot

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.

Study Overview

• Status: Withdrawn
• Conditions: Burns
• Intervention / Treatment: Other: Aquacel® Ag Burn Glove; Other: Mepilex® Transfer Ag; Drug: antibiotic

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Springfield, Illinois, United States, 62794-9640
      • Southern Illinois University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aquacel® Ag Burn Glove; Application of Aquacel® Ag Burn Glove burn dressing	Other: Aquacel® Ag Burn Glove; burn dressing; Other Names: ConvaTec
Active Comparator: Mepilex® Transfer Ag; Application of Mepilex® Transfer Ag burn dressing	Other: Mepilex® Transfer Ag; burn dressing; Other Names: Safetac®; Molnlycke® Health Care
Active Comparator: Xeroform®/Bacitracin®; Application of Xeroform® burn dressing and Bacitracin® topical antibiotic	Drug: antibiotic; antibiotic burn dressing; Other Names: Bacitracin®; Xeroform®

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life	quality of life measured by the psychosocial scales: Burn Specific Health Scale (BSHS)	baseline to 6 months post-burn injury
resilience	resilience measured by the Connor-Davidson Resilience Scale (CD-RISC)	baseline to 6 months post-burn injury

Collaborators and Investigators

• Sponsor: Southern Illinois University
• Investigators: Principal Investigator: Nada N Berry, MD, Southern Illinois University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Robson MC, Smith DJ Jr, VanderZee AJ, Roberts L. Making the burned hand functional. Clin Plast Surg. 1992 Jul;19(3):663-71.
• 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.
• 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.
• Hollinger MA. Toxicological aspects of topical silver pharmaceuticals. Crit Rev Toxicol. 1996 May;26(3):255-60. doi: 10.3109/10408449609012524.

Helpful Links

• Institute for Plastic Surgery, Office for Clinical Research

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: July 23, 2014
• First Submitted That Met QC Criteria: December 11, 2014
• First Posted (Estimate): December 17, 2014

Study Record Updates

• Last Update Posted (Estimate): July 21, 2016
• Last Update Submitted That Met QC Criteria: July 20, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: scar; thermal; burns; wound healing; hand; dressing; scarring; partial thickness; Aquacel®; Mepilex® Transfer Ag; Xeroform®; Bacitracin®; epithelialization
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Anti-Infective Agents, Local; Anti-Infective Agents; Gastrointestinal Agents; Laxatives; Anti-Bacterial Agents; Carboxymethylcellulose Sodium; Bacitracin
• Other Study ID Numbers: ABR-SIUSOM-14-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO