Cold atmospheric pressure plasma for treatment of chronic wounds: Drug or medical device?

A. Kramer, B. R. Conway, K. Meissner, F. Scholz, B. H. Rauch, A. Moroder, A. Ehlers, A. J. Meixner, C. D. Heidecke, L. I. Partecke, M. Kietzmann, O. Assadian

Research output: Contribution to journalArticle

7 Citations (Scopus)

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 physicians, surgeons, pharmacists, physicists and lawyers has analysed the physical and technical characteristics as well as legal conditions of the biological action of CAPP. Results: It was concluded that the mode of action of the locally generated CAPP, with its main active components being different radicals, is pharmacological and not physical in nature. Conclusion: Depending on the intended use, CAPP should be classified as a drug, which is generated by use of a medical device directly at the point of therapeutic application. Declaration of interest: None to declare.

LanguageEnglish
Pages470-475
Number of pages6
JournalJournal of wound care
Volume26
Issue number8
DOIs
Publication statusPublished - 10 Aug 2017

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Atmospheric Pressure
Equipment and Supplies
Wounds and Injuries
Pharmaceutical Preparations
Medical Economics
Therapeutics
Lawyers
Pharmacists
Wound Healing
Uncertainty
Pharmacology
Exercise
Physicians

Cite this

Kramer, A. ; Conway, B. R. ; Meissner, K. ; Scholz, F. ; Rauch, B. H. ; Moroder, A. ; Ehlers, A. ; Meixner, A. J. ; Heidecke, C. D. ; Partecke, L. I. ; Kietzmann, M. ; Assadian, O. / Cold atmospheric pressure plasma for treatment of chronic wounds : Drug or medical device?. In: Journal of wound care. 2017 ; Vol. 26, No. 8. pp. 470-475.
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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 physicians, surgeons, pharmacists, physicists and lawyers has analysed the physical and technical characteristics as well as legal conditions of the biological action of CAPP. Results: It was concluded that the mode of action of the locally generated CAPP, with its main active components being different radicals, is pharmacological and not physical in nature. Conclusion: Depending on the intended use, CAPP should be classified as a drug, which is generated by use of a medical device directly at the point of therapeutic application. Declaration of interest: None to declare.",
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Kramer, A, Conway, BR, Meissner, K, Scholz, F, Rauch, BH, Moroder, A, Ehlers, A, Meixner, AJ, Heidecke, CD, Partecke, LI, Kietzmann, M & Assadian, O 2017, 'Cold atmospheric pressure plasma for treatment of chronic wounds: Drug or medical device?', Journal of wound care, vol. 26, no. 8, pp. 470-475. https://doi.org/10.12968/jowc.2017.26.8.470

Cold atmospheric pressure plasma for treatment of chronic wounds : Drug or medical device? / Kramer, A.; Conway, B. R.; Meissner, K.; Scholz, F.; Rauch, B. H.; Moroder, A.; Ehlers, A.; Meixner, A. J.; Heidecke, C. D.; Partecke, L. I.; Kietzmann, M.; Assadian, O.

In: Journal of wound care, Vol. 26, No. 8, 10.08.2017, p. 470-475.

Research output: Contribution to journalArticle

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T2 - Journal of wound care

AU - Kramer, A.

AU - Conway, B. R.

AU - Meissner, K.

AU - Scholz, F.

AU - Rauch, B. H.

AU - Moroder, A.

AU - Ehlers, A.

AU - Meixner, A. J.

AU - Heidecke, C. D.

AU - Partecke, L. I.

AU - Kietzmann, M.

AU - Assadian, O.

PY - 2017/8/10

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N2 - 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 physicians, surgeons, pharmacists, physicists and lawyers has analysed the physical and technical characteristics as well as legal conditions of the biological action of CAPP. Results: It was concluded that the mode of action of the locally generated CAPP, with its main active components being different radicals, is pharmacological and not physical in nature. Conclusion: Depending on the intended use, CAPP should be classified as a drug, which is generated by use of a medical device directly at the point of therapeutic application. Declaration of interest: None to declare.

AB - 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 physicians, surgeons, pharmacists, physicists and lawyers has analysed the physical and technical characteristics as well as legal conditions of the biological action of CAPP. Results: It was concluded that the mode of action of the locally generated CAPP, with its main active components being different radicals, is pharmacological and not physical in nature. Conclusion: Depending on the intended use, CAPP should be classified as a drug, which is generated by use of a medical device directly at the point of therapeutic application. Declaration of interest: None to declare.

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