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The Burn Glove Trial - Hand Burn Dressing Pilot

Primary Purpose

Burns

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aquacel® Ag Burn Glove
Mepilex® Transfer Ag
antibiotic
Sponsored by
Southern Illinois University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring hand, burns, thermal, dressing, Aquacel®, Mepilex® Transfer Ag, Xeroform®, Bacitracin®, partial thickness, epithelialization, wound healing, scar, scarring

Eligibility Criteria

8 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southern Illinois University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Aquacel® Ag Burn Glove

Mepilex® Transfer Ag

Xeroform®/Bacitracin®

Arm Description

Application of Aquacel® Ag Burn Glove burn dressing

Application of Mepilex® Transfer Ag burn dressing

Application of Xeroform® burn dressing and Bacitracin® topical antibiotic

Outcomes

Primary Outcome Measures

pain
pain as measured by the Patient and Provider Scar Assessment Scale

Secondary Outcome Measures

pain
pain as measured by the Michigan Hand Outcomes Questionnaire (MHQ)
pain
pain as measured by the Disabilities of the Arm, Shoulder and Hand Scale, Quick (QuickDASH)
functionality
functionality as measured by the Michigan Hand Outcomes Questionnaire (MHQ)
functionality
functionality as measured by the Disabilities of the Arm, Shoulder and Hand Scale, Quick (QuickDASH)
aesthetic appearance
scar formation and aesthetic appearance measured using the Vancouver Scar Scale
aesthetic appearance
scar formation and aesthetic appearance measured using the the Patient and Provider Scar Assessment Scale

Full Information

First Posted
July 23, 2014
Last Updated
July 20, 2016
Sponsor
Southern Illinois University
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1. Study Identification

Unique Protocol Identification Number
NCT02318056
Brief Title
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

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Due to reorganization.
Study Start Date
December 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southern Illinois University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
hand, burns, thermal, dressing, Aquacel®, Mepilex® Transfer Ag, Xeroform®, Bacitracin®, partial thickness, epithelialization, wound healing, scar, scarring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aquacel® Ag Burn Glove
Arm Type
Experimental
Arm Description
Application of Aquacel® Ag Burn Glove burn dressing
Arm Title
Mepilex® Transfer Ag
Arm Type
Active Comparator
Arm Description
Application of Mepilex® Transfer Ag burn dressing
Arm Title
Xeroform®/Bacitracin®
Arm Type
Active Comparator
Arm Description
Application of Xeroform® burn dressing and Bacitracin® topical antibiotic
Intervention Type
Other
Intervention Name(s)
Aquacel® Ag Burn Glove
Other Intervention Name(s)
ConvaTec
Intervention Description
burn dressing
Intervention Type
Other
Intervention Name(s)
Mepilex® Transfer Ag
Other Intervention Name(s)
Safetac®, Molnlycke® Health Care
Intervention Description
burn dressing
Intervention Type
Drug
Intervention Name(s)
antibiotic
Other Intervention Name(s)
Bacitracin®, Xeroform®
Intervention Description
antibiotic burn dressing
Primary Outcome Measure Information:
Title
pain
Description
pain as measured by the Patient and Provider Scar Assessment Scale
Time Frame
baseline to 6 months post-burn injury
Secondary Outcome Measure Information:
Title
pain
Description
pain as measured by the Michigan Hand Outcomes Questionnaire (MHQ)
Time Frame
baseline to 6 months post-burn injury
Title
pain
Description
pain as measured by the Disabilities of the Arm, Shoulder and Hand Scale, Quick (QuickDASH)
Time Frame
baseline to 6 months post-burn injury
Title
functionality
Description
functionality as measured by the Michigan Hand Outcomes Questionnaire (MHQ)
Time Frame
baseline to 6 months post-burn injury
Title
functionality
Description
functionality as measured by the Disabilities of the Arm, Shoulder and Hand Scale, Quick (QuickDASH)
Time Frame
baseline to 6 months post-burn injury
Title
aesthetic appearance
Description
scar formation and aesthetic appearance measured using the Vancouver Scar Scale
Time Frame
baseline to 6 months post-burn injury
Title
aesthetic appearance
Description
scar formation and aesthetic appearance measured using the the Patient and Provider Scar Assessment Scale
Time Frame
baseline to 6 months post-burn injury
Other Pre-specified Outcome Measures:
Title
quality of life
Description
quality of life measured by the psychosocial scales: Burn Specific Health Scale (BSHS)
Time Frame
baseline to 6 months post-burn injury
Title
resilience
Description
resilience measured by the Connor-Davidson Resilience Scale (CD-RISC)
Time Frame
baseline to 6 months post-burn injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nada N Berry, MD
Organizational Affiliation
Southern Illinois University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9640
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18843629
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.
Results Reference
background
PubMed Identifier
1633673
Citation
Robson MC, Smith DJ Jr, VanderZee AJ, Roberts L. Making the burned hand functional. Clin Plast Surg. 1992 Jul;19(3):663-71.
Results Reference
background
PubMed Identifier
18952379
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.
Results Reference
background
PubMed Identifier
19686881
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.
Results Reference
background
PubMed Identifier
17137719
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.
Results Reference
background
PubMed Identifier
8726163
Citation
Hollinger MA. Toxicological aspects of topical silver pharmaceuticals. Crit Rev Toxicol. 1996 May;26(3):255-60. doi: 10.3109/10408449609012524.
Results Reference
background
PubMed Identifier
15091147
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.
Results Reference
background
Links:
URL
http://www.siumed.edu/surgery/plastics/clinical-research.html
Description
Institute for Plastic Surgery, Office for Clinical Research

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The Burn Glove Trial - Hand Burn Dressing Pilot

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