The Burn Glove Trial - Hand Burn Dressing Pilot

Burns Clinical Trial

Official title:

The Burn Glove Trial-A Randomized Controlled Trial of Dressings for Partial Thickness Hand Burns

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02318056
• Other study ID #: ABR-SIUSOM-14-002
• Status: Withdrawn
• Phase: N/A
• First received: July 23, 2014
• Last updated: July 20, 2016
• Start date: December 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Southern Illinois University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

Specific Aim 3: To determine if one of three burn dressings promotes aesthetically superior healing results for partial thickness hand burns.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Other:
• Aquacel® Ag Burn Glove
burn dressing
• Mepilex® Transfer Ag
burn dressing

Drug:
• antibiotic
antibiotic burn dressing

Locations

Country	Name	City	State
United States	Southern Illinois University School of Medicine	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Southern Illinois University

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. Epub 2006 Nov 29. Review. — View 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. — View Citation

Hollinger MA. Toxicological aspects of topical silver pharmaceuticals. Crit Rev Toxicol. 1996 May;26(3):255-60. Review. — View 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. Review. — View Citation

Robson MC, Smith DJ Jr, VanderZee AJ, Roberts L. Making the burned hand functional. Clin Plast Surg. 1992 Jul;19(3):663-71. Review. — View 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. Review. — View 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. Review. Update in: Cochrane Database Syst Rev. 2013;3:CD002106. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	quality of life	quality of life measured by the psychosocial scales: Burn Specific Health Scale (BSHS)	baseline to 6 months post-burn injury	No
Other	resilience	resilience measured by the Connor-Davidson Resilience Scale (CD-RISC)	baseline to 6 months post-burn injury	No
Primary	pain	pain as measured by the Patient and Provider Scar Assessment Scale	baseline to 6 months post-burn injury	No
Secondary	pain	pain as measured by the Michigan Hand Outcomes Questionnaire (MHQ)	baseline to 6 months post-burn injury	No
Secondary	pain	pain as measured by the Disabilities of the Arm, Shoulder and Hand Scale, Quick (QuickDASH)	baseline to 6 months post-burn injury	No
Secondary	functionality	functionality as measured by the Michigan Hand Outcomes Questionnaire (MHQ)	baseline to 6 months post-burn injury	No
Secondary	functionality	functionality as measured by the Disabilities of the Arm, Shoulder and Hand Scale, Quick (QuickDASH)	baseline to 6 months post-burn injury	No
Secondary	aesthetic appearance	scar formation and aesthetic appearance measured using the Vancouver Scar Scale	baseline to 6 months post-burn injury	No
Secondary	aesthetic appearance	scar formation and aesthetic appearance measured using the the Patient and Provider Scar Assessment Scale	baseline to 6 months post-burn injury	No

External Links

•   Institute for Plastic Surgery, Office for Clinical Research