Consensus on the Benefits of the Exsurco Medical Amalgatome SD in the Treatment of Burns and Other Wounds

Elof Eriksson, MD, PhD; Peter Grossman, MD; Tim Pittinger, MD; Chandra Ellis, MD; Justin Gillenwater, MD; Tracee Short, MD

Disclosures

ePlasty. 2019;19(pb5) 

In This Article

Abstract and Introduction

Introduction

The most common nonpowered surgical instruments for debridement include the Humby knife and the Goulian Weck dermatome, which have remained relatively unchanged since the 1930s.[1,2] Clinicians, particularly in the burn and vascular care settings, have experienced the need to have access to a motorized, easy-to-use device for removal of the eschar. Such early excision and grafting will reduce the risk of infection and speed the healing process.[3] The accuracy in preserving healthy tissue remains a challenge, and it is desirable to be able to use a debriding tool that can remove the eschar more precisely.

In the early 2000s, powered devices that utilize waterjet, cavitating curette, or cavitating nonbladed flat surfaces were introduced for debridement. These technological introductions have proven beneficial and have typically brought benefit to smaller areas of necrosis treated in the outpatient setting.[4] While helpful in the preservation of healthy tissue and cosmesis, these technological advances do not address the needs when debriding large burns.[5]

To address excisional needs in large burns, surgeons must typically resort to use of the century-old standard of the handheld Humby and Goulian Weck knifes.

In 1949, the first tissue bank was created by Dr George Hyatt for the US Navy to procure donors and recover allograft tissue for use in surgery. The passage of the Uniform Anatomical Gift Act in 1968 was established to maximize opportunities for organ procurement organizations (OPOs) and tissue banks. With the creation of the American Association of Tissue Banks in 1976, the need for more effective and efficient excisional modalities was further emphasized. Driven by other concerns, such as tissue yield, cutting accuracy, and allograft uniformity, these organizations have led the way in the discovery of more precise and effective tissue removal and processing techniques.

In 2013, the Amalgatome MD device (Exsurco Medical, Wakeman, Ohio) was introduced to the OPOs and tissue bank operators as a new circular rotating ring-blade device based on the company's leadership in the protein processing industry and food preparation market. Both OPOs and tissue banks found the circular rotating ring-blade technology provided more controlled and consistent skin graft/allograft procurement as well as increasing tissue yields (Figure 1).

Figure 1.

Tissue bank allograft skin yield performance by recovery device.

These benefits in precision and yield have made the Amalgatome MD the industry standard for OPOs and tissue bank operators. Nearly 90% of all the split-thickness allograft skin used in the United States has been procured using the Amalgatome MD as seen in Figure 2.

Figure 2.

Percentages of market share for split-thickness allograft skin procured by recovery device.

In 2017, the makers of the Amalgatome MD (Exsurco Medical) adapted its technology for surgical use in the burn and hospital trauma centers. The Amalgatome SD shares a few features with traditional dermatomes, such as pneumatically powered capabilities for skin graft recovery (Figure 3). However, the Amalgatome SD has the unique indications to perform both skin grafting and wound debridement/excision. As with the predicate device used in OPOs and tissue banks, the Amalgatome SD features a unique circular rotating ring-blade set in the head of the handpiece, allowing the surgeon to rotate and advance the instrument in multiple directions and titrate cutting depth in a greater range of thicknesses while making an excisional pass

Figure 3.

The Amalgatome SD device.

A published animal study[6] on the Amalgatome SD demonstrated the device safety and efficacy in viability of collected tissues, speed of healing, and donor site biomechanics. This study demonstrated the unique Amalgatome SD mechanism of action to excise tissue with greater precision and with significantly easier maneuverability than a conventional dermatome that incorporates an oscillating straight blade. The same study determined that the grafts recovered with the Amalgatome SD are very consistent in their thickness.

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