The Burn Glove Trial - Hand Burn Dressing Pilot

Condition(s) targeted: Burns

Intervention: Aquacel Burn Silver (AG) glove (Other); antibiotic (Drug); Mepilex Transfer AG (Other)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: Southern Illinois University

Official(s) and/or principal investigator(s):
Nada N Berry, MD, Principal Investigator, Affiliation: Southern Illinois University

Overall contact:
Thereasa E Abrams, PhD, LCSW, Phone: 217-545-8129, Email: tabrams@siumed.edu

Specific Aim 1: The primary purpose of this pilot trial is to determine if one of three burn dressings promotes a more efficacious healing environment for partial-thickness hand burns based on the studies' primary and secondary objectives. Hypothesis 1: Days to complete wound healing of partial thickness hand burns will be decreased with the use of Hydrofiber and silicone-based dressings compared to Bacitracin and Xeroform, this institution's standard of care.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: wound healing

Secondary outcome:

pain

patient/provider wound assessment

Detailed description: There are various products on the market that are 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 the healing rates of partial thickness hand burns when treated with Xeroform/Bacitracin, Aquacel AG burn glove or Mepilex Transfer AG dressing. The goal of this study is to assess the efficacy of three dressing types and determine which promotes the most rapid, positive healing of burn wounds to the hand/s.

Minimum age: 8 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients presenting at Memorial Medical Center, St. Johns Hospital and 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

- In- and out-patients at Memorial Health Center, St. John's Hospital and SIU Health

Care.

- 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

- 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

Thereasa E Abrams, PhD, LCSW, Phone: 217-545-8129, Email: tabrams@siumed.edu

Southern Illinois University School of Medicine, Springfield, Illinois 62794-9640, United States; Not yet recruiting
Nada N Berry, MD, Principal Investigator
Theresa E Abrams, PhD, LCSW, Sub-Investigator
Shaun Mendenhall, MD, Sub-Investigator
Amanda J Ross, MD, Sub-Investigator

Institute for Plastic Surgery, Office for Clinical Research

Related 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. Review. Update in: Cochrane Database Syst Rev. 2013;3:CD002106.

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

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.

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.

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.

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

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.

Starting date: December 2014
Last updated: December 11, 2014