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Clinical Trial
. 2012 Aug;167(2):404-10.
doi: 10.1111/j.1365-2133.2012.10923.x. Epub 2012 Jul 10.

Successful and safe use of 2 min cold atmospheric argon plasma in chronic wounds: results of a randomized controlled trial

G Isbary  1 , J Heinlin, T Shimizu, J L Zimmermann, G Morfill, H-U Schmidt, R Monetti, B Steffes, W Bunk, Y Li, T Klaempfl, S Karrer, M Landthaler, W Stolz
Affiliations
Clinical Trial

Successful and safe use of 2 min cold atmospheric argon plasma in chronic wounds: results of a randomized controlled trial

G Isbary et al. Br J Dermatol. 2012 Aug.

Abstract

Background: The development of antibiotic resistance by microorganisms is an increasing problem in medicine. In chronic wounds, bacterial colonization is associated with impaired healing. Cold atmospheric plasma is an innovative promising tool to deal with these problems.

Objectives: The 5-min argon plasma treatment has already demonstrated efficacy in reducing bacterial numbers in chronic infected wounds in vivo. In this study we investigated a 2-min plasma treatment with the same device and the next-generation device, to assess safety and reduction in bacterial load, regardless of the kind of bacteria and their resistance level in chronic wounds.

Methods: Twenty-four patients with chronic infected wounds were treated in a prospective randomized controlled phase II study with 2 min of cold atmospheric argon plasma every day: 14 with MicroPlaSter alpha device, 10 with MicroPlaSter beta device (next-generation device) in addition to standard wound care. The patient acted as his/her own control. Bacterial species were detected by standard bacterial swabs and bacterial load by semiquantitative count on nitrocellulose filters. The plasma settings were the same as in the previous phase II study in which wounds were exposed for 5 min to argon plasma.

Results: Analysis of 70 treatments in 14 patients with the MicroPlaSter alpha device revealed a significant (40%, P<0.016) reduction in bacterial load in plasma-treated wounds, regardless of the species of bacteria. Analysis of 137 treatments in 10 patients with the MicroPlaSter beta device showed a highly significant reduction (23.5%, P<0.008) in bacterial load. No side-effects occurred and the treatment was well tolerated.

Conclusions: A 2-min treatment with either of two cold atmospheric argon plasma devices is a safe, painless and effective technique to decrease the bacterial load in chronic wounds.

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Figures

Figure 1
Figure 1
Patient during treatment with MicroPlaSter beta device.
Figure 2
Figure 2
Ultraviolet (UV) spectrum of the MicroPlaSter beta device in the range of 180–400 nm, with a special focus on the UVC spectrum. UV spectrum of the alpha device is identical, due to the same configurations.
Figure 3
Figure 3
Species/genera and Gram‐distribution of bacteria detected on wounds by weekly wound swabs (a) in MicroPlaSter alpha group and (b) in MicroPlaSter beta group. MRSA, methicillin‐resistant Staphylococcus aureus.
Figure 4
Figure 4
Left panel: MicroPlaSter alpha device. Significant reduction in bacterial count (40%, P < 0·016) in plasma‐treated area (blue bar) compared with standard wound care alone (red bar). Right panel: MicroPlaSter beta device. Highly significant reduction in bacterial count (23·5%, P < 0·008) in plasma‐treated area (blue bar) compared with standard wound care alone (red bar).
Figure 5
Figure 5
(a) Box plots of the log‐returns of the number of colonies of MicroPlaSter alpha group, N c indicating the reduction in bacterial count: −1·15 log reduction of bacterial load in plasma‐treated area compared with a −0·26 reduction in control area (P < 0·002). The y‐axis is defined as formula image, where formula image. is the number of colonies after (before) treatment, respectively. (b) MicroPlaSter beta group with median log reduction of −1·1 in treated area vs. a −0·69 reduction in control area (P < 0·002).
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