Assessment of a Helium/Argon-Generated Cold Atmospheric Plasma Device's Safety Utilizing a Pig Model.

The PlazMagik device is a dual-gas cold atmospheric plasma (CAP) system that was developed and used for skin rejuvenation and inflammation treatment. However, preclinical evaluation and optimization of plasma parameters are crucial for guaranteeing safety. Therefore, this study was performed to evaluate the safety of the PlazMagik device under multiple parameters with different gas resources (helium (He) and argon (Ar) gases) on pig dorsal skin. After application of PlazMagik to the pig's dorsal skin, temperature and visual assessments were observed immediately and for up to 30 days. All clinical parameters, including body weight and blood serum biochemistry, along with histopathological analysis (H&E, MT, VB, NBTC staining), were monitored pre-application and at 1, 7, 15, and 30 days post-application of the plasma device. Our results confirmed the safety of the machine at low-output energy settings, which showed gentle skin exfoliation but no tissue damage, while high-output settings led to the skin erosion effect, then developing erythema and coagulation. Ar gas resulted in more significant heat production and pathological changes than He under identical conditions. These findings emphasize the importance of the preclinical evaluation of the energy settings and gas selection on optimizing CAP system performance for safe clinical applications and appropriate application purposes.