Chronic wounds treated with cold atmospheric plasmajet versus best practice wound dressings: a multicenter, randomized, non-inferiority trial

Abstract

The use of phase-adapted wound dressings represents best practice (BP) in chronic wound treatment. However, efficacy is often limited and associated care requirements are high. Cold atmospheric plasmajet (CAP-jet) is a promising new therapeutic tool for these wounds. In the present multicenter, randomized, open-label, prospective, clinical trial, non-inferiority of the CAP-jet versus BP was assessed in 78 patients with infected or non-infected chronic wounds of different etiology. Primary outcome measure was the sum of granulation tissue, furthermore wound area reduction, healing rate, time to complete healing, changes in wound pH value, infection score, exudate level and local tolerability were assessed. In CAP-jet treated wounds compared to control, the sum of granulation tissue was significantly higher (p < 0.0001) and wound area reduced significantly faster (p < 0.001). Furthermore, wound pH value decreased significantly faster (p = 0.0123) and local infection was overcome more rapidly by CAP-jet therapy. In 58.97% CAP-jet- vs. 5.13% BP-treated patients, complete healing of chronic ulcers was documented after 6 weeks. Treatment with CAP-jet appeared not only non-inferior, but even superior to BP in all wound entities analyzed with a favorable tolerability profile. Thus, treatment with the CAP-jet provides beneficial effects in chronic wound treatment regarding promotion of the wound healing process.

Efficacy of Cold Atmospheric Plasma Therapy on Chronic Wounds: An Updated Systematic Review and Meta-Analysis of RCTs

“…Four trials [ 19 , 22 – 24 ] reported the reduction of wound area (unit: cm 2 ), with 98 patients in CAP group and 91 in control group. As the heterogeneity was detected ( I 2 = 18%), a fixed-effects model was used.…”

“…Characteristics of included studies are presented in Table 1. Eight studies [12][13][14][15][16][17][18][19][20] were conducted in Germany, three in Iran [21][22][23], one in Austria [24], and one in Thailand [20]. The 13 included studies involved a total of 477 participants, who were randomized either into CAP treatment group or control group.…”

“…Quality assessments of included studies are shown in Figure 2. Six studies [12,17,[20][21][22] reported the generation of random sequences, and three studies [12,14,24] reported allocation concealment. Appropriate blinding of patients was reported in only four studies [12,14,17,19].…”

“…Reduction of Wound Area. Four trials [19,[22][23][24] reported the reduction of wound area (unit: cm 2 ), with 98 patients in CAP group and 91 in control group. As the Computational and Mathematical Methods in Medicine (log N f c /N i c, where N f c /N i c is the number of colonies after (before) each treatment); 84 patients randomly assigned to the CAP group and 84 to the control group.…”

Improving the efficiency of crossbred Pradu Hang Dam chicken production for meat consumption using cold plasma technology on eggs

“…The effects of argon plasma on the growth of soybean sprouts and the regulatory mechanism of energy metabolism were studied 21 . Although cold plasma has great potential advantages in various industrial fields such as surface treatment 22 , seed germination 23 , 24 , wounds healing 25 , etc., the investigation of cold plasma applications in the poultry industry is still in its early stages 26 .…”