Treatment with the CPTpatch
For treatment, a CPTpatch must be applied to the wound area and using a CPTcube. Application of the wound dressing is simple and safe (Figure 1).
Treatment starts automatically after pressing the start/stop button on the CPTcube. After the treatment period of 2 minutes, which is defined internally by the device, has elapsed, the CPTcube automatically goes into standby mode. However, the treatment can be stopped at any time by pressing the Start/Stop button on the CPTcube. This interrupts the voltage supply to the CPTpatch and the CPTcube immediately goes into standby mode.
The treatment can be repeated as often as necessary until the desired therapeutic success has been achieved. However, it should be noted that there should be at least 24 hours between each plasma treatment. The treatment can and should be used adjuvantly to other forms of therapy or recommendations of the corresponding guidelines at the discretion of the treating physician. Following plasma treatment, the wound can be covered with commercially available wound dressings.
The active components explained.
Active components (excerpt from position paper on risk potential and application perspectives of cold atmospheric pressure plasma in medicine, NZPM)
According to current international research, the main active components of cold atmospheric pressure plasma are reactive nitrogen and oxygen species (RNS, ROS), UV radiation and electric fields.
Reactive nitrogen and oxygen species (RNS, ROS) are formed locally and for a short time by coupling electrical energy into gases that are not biologically active per se (argon, helium, nitrogen, oxygen, air as well as mixtures thereof) and subsequent interacting with adjacent media (atmospheric air, liquids, surfaces). In principle, the same reactive species are sometimes produced in the human body as part of normal metabolism and in some cases have important functions in controlling and mediating physiological and pathological processes. Briefly elevated doses of these RNS and ROS can be effectively detoxified by endogenous systems.
UV radiation is used medically in phototherapy and photochemotherapy, among other applications. In this context, as well as from the point of view of general personal and occupational safety, also outside the medical environment, limit values have been established for UV exposure, which are significantly lower in cold atmospheric pressure plasma devices.
Two important findings of basic plasma medical research in recent years are:
1. biological plasma effects on cells and in tissues are mediated by changes in the fluid cell environment.
2. oxidizing species, so-called reactive oxygen and nitrogen species (ROS, RNS), put into the liquid or formed in the liquid play a dominant role in biological effects induced by plasma action.
3. Ultraviolet Radiation (UV radiation).
UV-B radiation in particular is used in dermatology as part of phototherapy. According to the recommendations of the German Dermatological Society (DDG) on phototherapy and photochemotherapy, initial doses between 20 and 60 mJ/cm2 are recommended for broad-spectrum UV- B application (280-320 nm), depending on the skin type, and doses between 200 and 600 mJ/cm2 are recommended for narrow-spectrum UV-B treatment (311 nm) [30].
A comparison with solar radiation shows that the UV intensity emitted by the cold atmospheric pressure plasma sources used in clinical trials or approved as medical devices to date is far below that of sunlight [31-33].
For the plasma sources currently certified as medical devices, it has been shown that under the recommended conditions of use (working distance, treatment time), the maximum permissible daily UV dose is significantly undercut [34, 35].
4. Electric Fields
Electric fields can first be divided into direct and alternating fields. In addition, the pulsation of such signals as well as monophasic or biphasic modulation allows for a high parametric diversity. Technical frequencies are in the range of a few Hz up to the GHz range. Devices using only electric fields have been established for many years for application in and on the human body and can induce an electric current flow in biological tissue as a result of the electric fields. Regardless of the device, the use of electrical signals for electrostimulation offers a variety of proven applications in medical care. For example, cell movement of immune cells (macrophages and granulocytes) and migration of skin cells (keratinocytes) and corneal epithelium can be specifically influenced in response to an electric field, proliferation behavior of connective tissue cells (fibroblasts) is stimulated, and for new vessel formation (angiogenesis) and nerve growth, the electric field is also important. Finally, in vivo studies using electric fields have shown an antibacterial effect on both gram-negative and gram-positive bacteria [36-40].
In recent years, research in the field of bioelectricity has demonstrated significant links between endogenous electric fields and the wound healing process [41-43]. A meta-analysis by Gardner et al. was performed using data sets from 15 clinical trials with the aim of quantifying the effect of electrical stimulation (ES) on chronic wound healing. Treatments with ES achieved an average wound reduction of 22.2% per week, compared with only 9.1% in control groups [44]. In the published partial results of Cochrane Review #077, the healing success (wound closure) using electrical stimulation was compared with placebo control. This question was investigated in 13 of the 20 studies. The analysis showed that twice as many (OR=2.12; 95% CI: 1.55 – 2.90) wounds were healed by treatment with electrostimulation (verum) compared to controls [45].
Effect
Clinical dermatological studies have shown the following:
- Inactivation of healing-inhibiting wound germs, including MRSA.
- No formation of resistance
- Increase of microcirculation in the tissue
- Promotion of angiogenesis
- Stimulation of wound healing – independent of wound architecture
- Reduction of the pH value in the wound area
- Prompt onset of action
- Painless treatment
Studies on cold plasma
An extensive study shows the efficacy of cold plasma (jet plasma/DBD) by inactivating all 105 investigated and partly antibiotic-resistant wound germs (11 different species), which were placed on the intact skin (fingertips) of nine healthy volunteers for testing (32). The antimicrobial efficacy was confirmed by further studies. Thus, chronic wounds of 34 patients were treated with cold plasma or in combination with a wound antiseptic. The combination therapy showed the best efficacy [1].
In a monocentric, randomized, controlled clinical trial, seven patients each with chronic ulcers (at least 12 weeks old) were subjected to plasma treatment or no treatment in addition to normal wound care. The plasma source was a dielectric-disabled discharge powered by air. Wound healing occurred similarly to standard therapy, while wound areas colonized with bacteria decreased by a mean of 88% in wounds treated with Plasma [2].
Sixteen patients included in the study (ten women and six men) with chronic leg ulcers were each treated with cold plasma three times a week over a period of two weeks. In addition to measuring antimicrobial activity, the aim of the study was to investigate the effect on wound healing. The parameters compared were, in addition to the number of bacterial colonies per square centimeter, the size of the wound surface and the change in wound volume. The authors concluded that the immediate antimicrobial effect of the two treatment methods was largely comparable. Plasma therapy was very well tolerated by patients and, according to the authors, is unlikely to cause allergies due to its physical principle of action [4].
In a more extensive study with 70 patients, a tendency toward improved healing was determined in chronic ulcers treated with cold plasma – compared to untreated wounds [5]. In addition, another randomized-controlled trial with 40 patients showed significantly improved healing after plasma treatment of acute wounds after skin grafts [6]. A summary of the current status of plasma use in animal experiments, in vivo, and clinical studies and case reports is also the subject of a recent review [7].
A risk assessment with reference to plasma species (temperature, UV radiation and free radicals) did not reveal any increased risks for humans [8].
Based on the level of clinical research achieved, plasma applications in dermatology and plastic and aesthetic surgery currently have the highest prospects of success. The use of antimicrobial plasma effects, plasma-assisted stimulation of tissue regeneration, and inflammation-modulating plasma effects are the focus of therapeutic indications.
Side effects/tolerability of cold plasma
At the current state of clinical research, no clinically relevant side effects are known.
Reimbursement
Please contact the responsible staff member. Hier vielleicht der Link zur PZN ind Deutsch und der PPN in Englisch