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:
- On efficacy, consistency of the excised tissues was superior for the test device (Amalgatome SD) which may result in better grafts and better outcomes.
- Several aspects related to the ease of use, particularly maneuverability, were superior as well.
- 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.