電漿醫療器材領域中近幾年蓬勃發展，接受許多國際上的醫療法規審視，必須通過法規才能上市使用，也因使用在人體，安全性是醫材必須把關的首要議題。遂本研究將使用實驗室開發的非熱微電漿裝置，其為微噴流型式氦氣與混合氮氣的微電漿，觀察微電漿系統對人體是否有足夠的安全性。醫療器材在應用在人體之前需要經過足夠的臨床前實驗來證明其是否有足夠安全性，此階段的安全評估可以提供人體應用之前的信賴保證，讓人體試驗委員會IRB可以評估新興醫療器材的安全。本實驗即是針對臨床前實驗進行，評估方式使用大型動物豬作為模擬人體皮膚，此評估方式之基礎為人體皮膚構造生理上和豬隻皮膚構造相似，此研究將從豬皮膚的手術傷口對於微電漿系統不同電漿處理時間的反應。
本研究首先根據DIN德國法規所規範的標準實驗，進行電漿診斷並依照診斷結果作為臨床前實驗參數，法規內容的標準實驗可以證明微電漿裝置於操作期間有足夠安全性。以此參數進行豬隻傷口安全性實驗，採用手術切除方式在豬皮膚表面創造全皮層移除傷口，作為模擬急性傷口的模型。其中評估不同電漿處理時間還有純氣吹對照電漿處理的比較。
根據DIN法規之實驗，O3和NO2濃度皆符合安全濃度範圍、符合紫外光輻射強度標準。法規實驗確認了此微電漿參數之安全性，使用者於微電漿啟用期間可以安全進行操作而不會造成身體負擔。臨床前實驗量測結果由傷口縮合面積計算可以發現電漿處理1分鐘和1.5分鐘具有良好的傷口縮合率，和氣吹組相比電漿處理1.5分鐘實驗組別傷口縮合呈現出顯著差異。由組織染色分析可以發現豬隻皮膚傷口修復，發現電漿處理1.5分鐘具有近似正常皮膚之厚度，比起其他組別有顯著差異。此成效評估表示電漿處理1.5分鐘於生物安全性表現不會造成皮膚傷口的二度傷害，讓上皮不會延誤生長，有更好的傷口應用之安全性。此研究將可作為人體臨床試驗之前的安全標竿。

Non-thermal micro-plasma therapy is a novel medical device for wound care. A medical device should not, when used for the medical conditions, adversely affect health. Thus the safety of medical devices should be assessed using experiments. The present study examines safety according to DIN standards. Device effects are tested using preclinical trials on pigs to simulate human skin. The experimental design has two parts. The first part was plasma diagnosis according to DIN standards. The plasma plume temperature and reactive plasma species in N2/He micro-plasma were measured. The optimal micro-plasma temperature (below 37°C) and a high NO concentration were controlled by adjusting the supplied power and N2 content. Experiments were also conducted to determine the oxidizing gas concentration of the plasma, ultraviolet (UV) intensity distribution, pH value of water exposed to micro-plasma, and thermal power from plasma. In the second part of the experiment, the preclinical study-groups on pig’s back were examined after micro-plasma exposure. Six study groups were examined: (1) non-treatment group (control group) (2) 1-min plasma exposure; (3) 1.5-min plasma exposure; (4) 1-min gas flow; (5) 1.5-min gas flow, and (6) 2 and 3 min plasma exposure. In conclusion, the results showed that the optimal micro-plasma parameter was 13 W power supplied and He with 1.0% N2 addition. And the results of characteristic experiment of oxidation gas emission and UV radiation all meet to the DIN standards confirming the safety of non-thermal micro-plasma in device use. The measurement of pH value record and the thermal performance shows the mechanical characteristics as references for plasma source. In H&E images, 1.5-min plasma wound group had better wound safety for significant wound area reduction and the thinnest epidermal thickness in all groups. The preclinical wound groups in preclinical trials showed the possibilities and potential for clinical safety and application.

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