Can two plasma medical devices have the same clinical efficacy?

We have been asked by Health Care Professionals to clarify , “What is the difference between the Adtec SteriPlas (Adtec Healthcare) and other cold plasma technologies such as Plasma Care® ?” or “Can two different plasma technologies have the same clinical efficacy… what’s the difference?”.

The answers to these questions are that there is a significant difference between plasma technologies, and it is therefore not possible to claim a similarity in clinical efficacy as the plasma treatments would be different.

Two devices do not produce the same plasma and it is the composition of the plasma that exerts the effects, beneficial and detrimental. For the importance of patient safety, Adtec Healthcare advises against any other plasma device claiming clinical efficacy from the clinical evidence of the CE approved SteriPlas gas plasma. Adtec’s clinical data should never be used to compare to any other plasma treatment which have not yet been clinically tested.

Atmospheric pressure Plasma has a myriad of potential medical applications from low energy plasmas used for wound healing to higher energy plasmas used to cut bones during an operation or for coagulation. The main differences in all plasma technologies include the different forms of plasmas electrode source designs, types of energy used (RF, DC and microwave) and gas used (argon, helium or nitrogen etc) versus air. The Adtec SteriPlas (MicroPlaSter) plasma technology is based on a microwave powered plasma jet utilising argon gas and the other technology is a DC powered Surface Micro Discharge (SMD) plasma source utilising air as carrier gas. The type of plasma generated corresponds directly to the type of treatment delivered to the patient.  Each type of plasma delivers a specific type of treatment.

During the pre-clinical trials and studies, Max Planck had conducted a study illustrating the noticeable differences of our argon gas microwave plasma treatment vs the surface micro-discharge (SMD) ‘Air plasma’ treatment developed at MPI. In this study, clear distinctions could be observed such as argon gas plasma treatment included predictable, safe and low dosages of reactive species whereas air-based plasmas would deliver significantly higher concentrations (over 37 times more than argon microwave plasma).  Air Plasma has much higher levels of NOx and Ozone than argon gas plasma and needs to be tested not only clinically but also safety for the operator. It is essential to verify the product safety and clinical safety of these higher levels of NOx. The air-based plasmas are also generally dependent on the surrounding environment; temperature and humidity will affect the way the plasmas are generated and therefore difficult to deliver the same treatment each time the plasma is generated.

Adtec Plasma Technology has been at the forefront for the development of plasma products for over 30 years, proudly placing us as one of the leaders in the semiconductor and RF plasma market. Adtec has also developed other plasma technologies (gas and air) for remote plasma, gas abatement and surface treatment applications.

In 2002, we designed our first cold plasma technology showing painless effect on contact with human skin. This revolutionised the way how we are used to dealing with plasmas – typically sought as too hot to touch but now redesigned to be colder and harmless on contact with skin. In 2004, our research results were presented at a plasma conference showing distinctive microbial load reduction was possible when bacteria were exposed to our gas plasma.

Later in 2004, Adtec introduced this plasma technology to the Max Planck Institute for Extraterrestrial Physics leading to a collaboration in plasma medicine. The Adtec plasma source was adapted to a wide area plasma source in collaboration with MPI.  This plasma source of the medical device is a shared patent with Adtec and MPI (as seen in the image below). This plasma source is one of the critical components used in the SteriPlas and MicroPlaSter. Adtec solely and exclusively designed and developed the medical device prototypes and products including customized components, electrical, mechanical and software program satisfying the strict standards of European medical device regulations.

We are grateful to the plasma medicine team at Max Planck for having an interest in our plasma technology system, for carrying out extensive scientific research and for managing the clinical trials using the Adtec MicroPlaSter. These clinical trials placed our medical device as the first worldwide to be used in clinical trials on wounds, paving a new treatment programme that would later be adopted by other companies with an interest to develop gas plasma medical devices.  The extensive research and clinical testing assure us of the safety of the product and the technology.

The new European MDR regulations coming into force next year also require all companies to produce proper clinical evidence to support their product claims. We do emphasize the importance of proper pre-clinical and clinical testing of all types of plasma technologies in order to be assured of the product and clinical safety. Adtec Healthcare do encourage and support plasma companies in this industry as our goal is to make gas plasma a recognised treatment option for patients with wounds, surgical site infections and dermatological conditions.


EWMA

We had a great time exhibiting at the EWMA 2019 conference. We would like to congratulate Maurice Moelleken, Dr Heinrich Rotering and Dr Michael Pierides for their brilliant presentations during the conference. Their data showed the strong benefits of using the Adtec SteriPlas on chronic wounds and surgical site infections, offering an alternative to standard treatment therapies that bacteria may pose a resistance to.

The Adtec SteriPlas has proven antibacterial efficacy backed by a wide clinical bibliography and no side effects reported making it safe, painless and effective for the treatment of infected wounds stalled by bacteria.

For more information send us an email to info@adtec.eu.com

Top left (Dr Michael Pierides), top right (Maurice Moelleken), bottom (Dr Heinrich Rotering)

#EWMA #EWMA2019 #antimicrobialresistance #medicaldevice
#gasplasma #coldplasma #kaltesplasma


Poster presentation at the International Symposium on the Diabetic Foot Conference, Hague.

Wednesday 22nd May 2019

A great poster presentation from Dr Aye Aye Thant at the ISDF 2019 conference!

Dr Thant’s presentation demonstrated the benefits of using the Adtec SteriPlas on diabetic foot ulcer patients.

Prior to the use of the Adtec SteriPlas, all patients in their retrospective study suffered from chronic and non-healing foot and leg ulcers with multi resistant bacteria and recalcitrance to antibiotics. All patients had at least 3 courses of intravenous antibiotics for more than 6 weeks prior with poor response.

The Adtec SteriPlas was then introduced as a treatment option. Instantly, positive results could be seen with the infection management for these patients. For example, one patient who was previously considered for an amputation was now improved and risk free. Healthy granulation could be observed with all patients, offering hope and an alternative to antibiotics that would usually be offered.

For more information on the Adtec SteriPlas, visit our website www.adtecplasma.com or send us an email at info@adtec.eu.com


Mr Keith Cutting presents significant results on DFUs in Vienna conference

Mr Keith Cutting presented at The European Conference on Controversies in Diabetic Foot Management conference in Vienna last week. His presentation focused on the benefits of treating complex diabetic foot ulcer patients with the Adtec SteriPlas.

The Adtec SteriPlas has shown promising results leading to healing in problematic and non-healing wounds such as diabetic foot ulcers or surgical site infections. These complex wounds that have shown signs of stalled healing respond well to intervention with the Adtec SteriPlas.

To learn more about our medical device and the benefits it offers to patients with wounds, surgical site infections and dermatological conditions send us an email at info@adtec.eu.com


Adtec SteriPlas featured in conference presentations for 2019

Adtec Healthcare is excited to attend and support the clinicians presenting at the following conferences for 2019:

The European Conference on Controversies in Diabetic Foot Management conference in Vienna, 2nd – 3rd May 2019 (https://www.diabeticfoot-europe.com/).
Mr Keith Cutting will be conducting an oral presentation on Friday 3
rd May at 14:00. His presentation is titled, “Interim Results from Currently Running Study on the Treatment of Biofilm Infection in Diabetic Foot Ulcers Using Gas Plasma”.

The ISDF 2019 conference in The Netherlands, 22nd – 25th May 2019 (https://diabeticfoot.nl/).
Dr Aye Aye Thant from Kettering General Hospital NHS Foundation Trust will be conducting a poster presentation on “Adtec Cold Plasma Treatment to Assist in Treating Diabetic Foot with Multi Resistant Infection”. This will be presented on Wednesday 22
nd May from 12:10.

The European Wound Management Association (EWMA) conference in Gothenburg, Sweden, 5th – 7th June 2019 (https://ewma.org/ewma-conference/2019/). Presenting clinical evidence at this conference will be:

Maurice Moelleken from the Universitätsklinikum Essen, Germany. Maurice’s oral presentation on “Prospective RCT to validate the interval of cold atmospheric plasma treatment for reduction of bacterial load, wound area and pain in patients with chronic wounds” will be presented on 6th June at 08:50am.

Dr Michael Pierides from Kettering General Hospital NHS Foundation Trust will have an e-poster at the EWMA conference. His poster, “The Gas Plasma Medical Device: A Novel Therapy in Treating Non-Resolving Infected Diabetic Foot and Leg Ulcers” can be viewed throughout the conference.

Dr Heinrich Rotering from the Universitätsklinikum Münster, Germany will be conducting a poster presentation, “Cold Plasma and Advanced Negative Pressure Wound Treatment – Long Term Follow Up of Treated Infected Implants in Cardiac Surgery”, on 6th June between 09:42 – 09:45.

The Surgical Infection Society Europe conference in Dublin, Ireland, 26th – 28th June (http://sis-e.org/2019/).
Dr Heinrich Rotering will have a poster at this conference. His poster, “Infection of Cardiovascular Implantable Electronic Devices (CIED) – New Approach with Cold Atmospheric Plasma (CAP)” can be viewed throughout the conference.

Adtec Healthcare staff will be present at these conferences to support the presenting speakers and welcome any meetings. Please get in contact with us at info@adtec.eu.com to secure your meeting in advance.


Gas plasma shows promising results in the treatment of non-healing wounds

Renowned for its ability to successfully treat non-healing wounds, the Adtec SteriPlas is a must have for any dermatology and wound care departments.

This 61-year-old patient with a long-term venous ulcer was stalled from healing and present with Klebsiella oxytoca and Enterobacter cloacae. The patient went through a short treatment programme with our gas plasma medical device to achieve exceptional results. Figures (a) - (b) shows the visual changes of the ulcer throughout the short course of treatment with the Adtec SteriPlas.

Figure (a) shows the patient's ulcer at the start of the treatment
Figure (b) shows after 7 applications of our gas plasma.
Figure (c) shows after 11 treatments of our gas plasma.

At the end of the treatment programme, swabs which would normally have shown signs of bacteria were now sterile, allowing the patient to further progress into full healing.

Interested to hear more? Reach out to us at info@adtec.eu.com


Surgical site infections treated with the Adtec SteriPlas

Surgical site infections (SSIs) are still a severe complication after cardiac surgery with a mortality estimated range of up to 40% of cases. These post-operative wounds are generally associated with longer hospital stay and the delayed or inadequate therapeutic measures can lead to avoidable hospital costs for the healthcare system. The significant cost burden on the hospital for a single SSI case is €36,000. 1

It has already been shown that the Adtec SteriPlas is effective due to its increased penetration depth in SSIs to defeat bacteria even under a layer of biofilm independently to their resistance profile. This includes multi-resistant bacteria that have shown little or no response to antibiotics previously. In combination with advanced negative pressure wound treatment (aNPWT), the Adtec SteriPlas has been praised as a “tissue saving approach” offering patients a favourable treatment method for these complicated and chronic wounds compared to conventional treatment therapies. 2

Studies conducted using the Adtec SteriPlas have shown a significant decrease in the mortality rate coupled with accelerated healing. Patients with infected drivelines such as those with left ventricular assist devices have healed in as quick as 1 week, and patients with sternal SSIs have healed in as quick as 6 days. 2,3

The table above shows Dr H. Rotering’s recent data presented at the Chirurgie 2019 conference. The table explains that patients with infected drivelines have healed in as quick as 1 minute.

Both patients and doctors have praised the Adtec SteriPlas for its exceptional ability at delivering promising results leading to healing.

Be sure to contact us for more information and to see how our medical device may benefit your patients.

  1. H. Rotering, Cold atmospheric plasma – New options for infection control in wound management, EWMA 2016.
  2. H. Rotering, Cold atmospheric plasma and advanced Negative Pressure Wound Treatment – First results of a tissue saving approach for deep surgical site infections, EACTS 2018.
  3. H. Rotering, Das infizierte Implantat, Komplexe Wundbehandlung – Kaltes atmospherisches Plasma und advanced NPWT in der Herzchirurgie, Chirurgie 2019.

Promising results for the treatment of diabetic foot ulcers using the Adtec SteriPlas

We are excited to show you a recent conference poster presented at the BSAC Spring 2019 conference, submitted by Kettering General Hospital NHS Foundation Trust.

The poster shows the promising results of the using the Adtec SteriPlas on diabetic foot ulcers that are stalled by biofilm. The SteriPlas “is postulated as an alternative for antibiotics for patients where antibiotic therapy is difficult (due to resistance or adverse effects) or as an adjunct treatment for patients with chronic wounds including those with biofilms”.

Contact us at info@adtec.eu.com to learn more about how the Adtec SteriPlas may benefit your non-healing wound patients.