March 7, 2022

Gold-standard study proves superiority of the plasmajet kINPen® MED over best practice wound treatmant for wound closure of chronic wounds

The results

Advantages of the plasmajet kINPen® MED (Cap-jet) vs. best practice (BP)

  • Acceleration of wound healing and wound closure proven
  • 59 % of patients on Cap-jet with wound closure vs. 5.1 % on BP
  • 100 % complete subsidence of wound infections
  • significantly faster reduction of wound area: 95.1  granulation tissure closure under Cap-jet vs. 74.6 % with BP
  • shorter time to wound closure
  • improved exudate management

Patients can gain new quality of life

  • better local tolerance
  • lower pain burden

Population

78 infected and non-infected chronic wounds of different etiology

    • Patients with venous leg ulcers, arterial leg ulcers, mixed leg ulcers (venous and arterial involvement), diabetic foot ulcers, pressure ulcers
    • Average age: 68.7 years

Study Centres
2 hospitals in Austria

    • State Hospital Feldkirch
    • State Hospital Bregenz

 

 

Methodology

Randomisation of 78 patients into 2 treatment groups

    • 39 patients in the Cap-jet group: therapy with kINPen® MED (30 s/qcm wound area each); wounds covered with gauze and fixation bandage
    • 39 patients in the best practice group (BP): Treatment with an appropriate wound dressing, including an antiseptic treatment of infected wounds.

In both groups, patients with venous ulceration received compression therapy.

Primary study objective

Investigation of the effectiveness of Cap-jet treatment in infected and non-infected wounds of different etiology by amount of granulation tissue

 

Reference:

Strohal R, Dietrich S, Mittlböck M, Hämmerle G. Chronic wounds treated with cold atmospheric plasmajet versus best practice wound dressings: a multicenter, randomized, non-inferiority trial. Sci Rep. 2022 Mar 7;12(1):3645. doi: 10.1038/s41598-022-07333-x.

 

July 22, 2020

The world’s first placebo controlled clinical trial confirms the successful application of the kINPen® MED plasma jet in the treatment of diabetic foot ulcera: Reactivation and acceleration of wound healing scientifically confirmed

The Study

Population
65 diabetic foot wounds

  • Adult patients with diabetic foot syndrome
  • Wagner-Armstrong Classification grade 1 B and 2 B
  • Average age: 68.5 years (standard deviation 9.1 years)

Study centres
Two German hospitals:

  • HDZ NRW, University Hospital for the treatment of cardiac, vascular and diabetic diseases of the Ruhr University of Bochum, Bad Oeynhausen, Germany
  • Medical centre for cardiac and diabetic diseases, Karlsburg, Germany)

Methodology
62 wounds were randomised

  • 31 wounds treated with standard wound therapy plus cold atmospheric plasma (CAP): 8 CAP applications (30s/cm² wound surface) within 14 days
  • 31 wounds treated with standard wound therapy plus placebo control: 8 applications of placebo (simulated plasma) within 14 days

Primary study endpoints
Reduction of wound surface, the infection status of the wound and microbial load compared to the start of the therapy

Results

Reduction of wound surface
After 8 treatments, the CAP therapy achieved the following results when compared to the placebo (measured at visit No. 9):

  • Significant increase of wound healing
  • Reduction of overall wound surface
  • Faster relevant reduction of wound surface

Effect of cold plasma on activation of wound healing

  • CAP superior to placebo with regard to infection status and microbial load reduction
  • The results confirm that atmospheric cold plasma has its own inherent activating effect on wound healing

Potential shorter hospitalisation of DFS patients

Reference:
Stratmann B., Costea T. C., Nolte C. et al. Effect of cold atmospheric plasma therapy vs standard therapy placebo on wound healing in patients with diabetic foot ulcers: a randomized clinical trial. JAMA Netw Open. 2020; 3 (7): e2010411. doi: 10.1001 / jamanetworkopen.2020.10411