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BurnsNCT02318056

The Burn Glove Trial - Hand Burn Dressing Pilot

A study testing Aquacel® Ag Burn Glove, Mepilex® Transfer Ag and antibiotic in people with Burns, run by Southern Illinois University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 60 years
Conditions the study is for
Burns
What is being tested?
Aquacel® Ag Burn Glove, Mepilex® Transfer Ag and antibiotic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Dec 2015to Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • < 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62794-9640

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Burns
Being tested
Aquacel® Ag Burn Glove, Mepilex® Transfer Ag, antibiotic
Keywords
hand, burns, thermal, dressing, Aquacel®, Mepilex® Transfer Ag, Xeroform®, Bacitracin®, partial thickness, epithelialization, wound healing, scar, scarring
Medical subject headings
Burns, Cicatrix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aquacel® Ag Burn GloveOther

    Also called ConvaTec

    burn dressing

  • Mepilex® Transfer AgOther

    Also called Safetac®, Molnlycke® Health Care

    burn dressing

  • antibioticDrug

    Also called Bacitracin®, Xeroform®

    antibiotic burn dressing

Study groups in NCT02318056
Study groupRoleWhat they receive
Aquacel® Ag Burn GloveExperimentalApplication of Aquacel® Ag Burn Glove burn dressing
Receives: Other: Aquacel® Ag Burn Glove
Mepilex® Transfer AgActive comparatorApplication of Mepilex® Transfer Ag burn dressing
Receives: Other: Mepilex® Transfer Ag
Xeroform®/Bacitracin®Active comparatorApplication of Xeroform® burn dressing and Bacitracin® topical antibiotic
Receives: Drug: antibiotic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain

    pain as measured by the Patient and Provider Scar Assessment Scale

    Measured: baseline to 6 months post-burn injury

Secondary outcomes (6)

  1. pain

    pain as measured by the Michigan Hand Outcomes Questionnaire (MHQ)

    Measured: baseline to 6 months post-burn injury

  2. pain

    pain as measured by the Disabilities of the Arm, Shoulder and Hand Scale, Quick (QuickDASH)

    Measured: baseline to 6 months post-burn injury

  3. functionality

    functionality as measured by the Michigan Hand Outcomes Questionnaire (MHQ)

    Measured: baseline to 6 months post-burn injury

  4. functionality

    functionality as measured by the Disabilities of the Arm, Shoulder and Hand Scale, Quick (QuickDASH)

    Measured: baseline to 6 months post-burn injury

  5. aesthetic appearance

    scar formation and aesthetic appearance measured using the Vancouver Scar Scale

    Measured: baseline to 6 months post-burn injury

  6. aesthetic appearance

    scar formation and aesthetic appearance measured using the the Patient and Provider Scar Assessment Scale

    Measured: baseline to 6 months post-burn injury

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2014 (estimated)
  2. Study startDec 2015
  3. Primary completionJul 2016
  4. Study completionJul 2016

Why it stopped: Due to reorganization.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02318056
Sponsor's protocol ID
ABR-SIUSOM-14-002
Status last verified
Jul 2016
First submitted
23 Jul 2014
Last updated
21 Jul 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 18843629

  • Robson MC, Smith DJ Jr, VanderZee AJ, Roberts L. Making the burned hand functional. Clin Plast Surg. 1992 Jul;19(3):663-71.

    PubMed 1633673

  • 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.

    PubMed 18952379

  • 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.

    PubMed 19686881

  • 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.

    PubMed 17137719

  • Hollinger MA. Toxicological aspects of topical silver pharmaceuticals. Crit Rev Toxicol. 1996 May;26(3):255-60. doi: 10.3109/10408449609012524.

    PubMed 8726163

  • 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.

    PubMed 15091147

Questions about this trial

What is this clinical trial studying?

A study testing Aquacel® Ag Burn Glove, Mepilex® Transfer Ag and antibiotic in people with Burns, run by Southern Illinois University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain (time frame: baseline to 6 months post-burn injury). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02318056, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2016.

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