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2017
DOI: 10.12968/jowc.2017.26.8.470
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Cold atmospheric pressure plasma for treatment of chronic wounds: drug or medical device?

Abstract: Objective: The use of cold atmospheric pressure plasma (CAPP) as a new therapeutic option to aid the healing of chronic wounds appears promising. Currently, uncertainty exists regarding their classification as medical device or medical drug. Because the classification of CAPP has medical, legal, and economic consequences as well as implications for the level of preclinical and clinical testing, the correct classification is not an academic exercise, but an ethical need. Method: A multidisciplinary team of phys… Show more

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Cited by 14 publications
(8 citation statements)
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References 83 publications
(71 reference statements)
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“…Meanwhile, first case reports exist on beneficial plasma effects in cancer patients. The kINPen MED is accredited as medical device in Germany and the European Union for skin surface treatment and decontamination [ 57 ], although the classification as a device is at least controversial for wound treatment [ 58 ]. Final stage head and neck cancer patients often suffer from microbial infections [ 59 ].…”
Section: Introductionmentioning
confidence: 99%
“…Meanwhile, first case reports exist on beneficial plasma effects in cancer patients. The kINPen MED is accredited as medical device in Germany and the European Union for skin surface treatment and decontamination [ 57 ], although the classification as a device is at least controversial for wound treatment [ 58 ]. Final stage head and neck cancer patients often suffer from microbial infections [ 59 ].…”
Section: Introductionmentioning
confidence: 99%
“…For more details, refer to Figure 2 belongs to the group of direct cold plasma sources, whose mode of operation is based on integrating the treated tissue into the electrical circuit, inducing a stimulating electric current flow into the tissue in the presence of strong electric fields in addition to exposure to reactive oxygen and nitrogen species, charged particles, and mild UV-A radiation. The manufacturer declared the conformity according to EU Guideline 93/42/EEC for medical devices, although the classification of plasma medical devices for wound treatment seems controversial [35,36]. Pursuant to the manufacturer, the treatment area of the class IIa medical device covered 27.5 cm 2 , in which a low-temperature plasma is ignited directly in the ambient air layer, covering the skin surface.…”
Section: Cap Applicationmentioning
confidence: 99%
“…The energy source needed to create plasma may be thermal, chemical or electrical in nature [1]. Based on its thermal properties, the role of plasma in medicine has expanded to include a wide range of applications including cancer [2], wound healing [3], infectious disease [4], and dentistry [5]. Plasma is also being used with increasing frequency in dermatology [6].…”
Section: Introductionmentioning
confidence: 99%