Report on Three Porcine Proof-of-concept Studies: Comparison of a Dermatome With a Rotating Excision Ring With Conventional Dermatomes for the Harvesting of Split Skin Grafts and Excision of Necrosis.

INTRODUCTION

A new pneumatic dermatome with a circular excision blade was designed to improve a number of disadvantages of regular dermatomes.

OBJECTIVE

This study analyzes the safety and efficacy of a new dermatome (test device) for the tangential excision of necrosis and harvesting of split-thickness skin grafts (STSGs).

MATERIALS AND METHODS

Three porcine proof-of-concept studies were conducted to compare the test dermatome with conventional dermatomes (control devices) for both excision of necrosis (one study) and the harvesting of a STSG (2 studies). For the harvesting studies, donor sites and grafts were analyzed for viability, healing rate, and scar outcomes. Biomechanical tests also were performed on the donor sites. For the necrotectomy study, healing of the excised area and thickness of the excised tissues were studied.

RESULTS

The test device was similar to the control devices in viability of collected tissues, speed of healing, and donor site biomechanics. In 1 graft harvesting study, as well as in the excision study, uniformity of the thickness of the harvested tissues was better for the test device than for the control devices. The test device performed better than the controls on maneuverability, control of the consistency of the relationship between depth setting and actual graft thickness, device assembly, overall ease of use, depth of the debridement as intended, consistency of the debridement thickness, device accuracy, and size.

CONCLUSIONS

The studies showed the test device, when compared with the control devices, was equal on safety. On efficacy, consistency of the excised tissues was superior for the test device, which may result in better grafts and outcomes. Several aspects related to the ease of use, particularly maneuverability, were superior as well.