Clinical proof-of-concept study on split-thickness skin grafting and excision of necrosis

White Paper Overview

Three (3) proof-of-concept, porcine studies were used to analyze safety and efficacy of a new dermatome for the tangential excision of necrosis in a deep partial thickness burn model and the harvesting of split-thickness skin grafts.*

  • The new device, Amalgatome® SD, is a pneumatic dermatome which uses a circular excision blade that rotates at high speed and has a dissection range of 180 degrees.
  • The Amalgatome SD was designed to increase ease of use and to obtain a higher degree of consistency of the excised tissues.

Conclusion: The following outcomes were obtained:

  1. On efficacy, consistency of the excised tissues was superior for the test device (Amalgatome SD) which may result in better grafts and better outcomes.
  2. Several aspects related to the ease of use, particularly maneuverability, were superior as well.
  3. The study showed that the test device (Amalgatome SD), when compared to the control devices, was equal on safety.

*Standard dermatomes were used as the control device in the study: excisions and graft harvesting were performed in a randomized way.

Amalgatome SD in use - Exsurco Medical