Bakker Olaf, Smits Paulien, van Weersch Chantal, Quaaden Melissa, Bruls Esther, van Loon Angela, van der Kleij Joost
St. Antonius hospital, Nieuwegein, The Netherlands.
Plasmacure B.V., Eindhoven, The Netherlands.
Adv Wound Care (New Rochelle). 2025 Jan;14(1):1-13. doi: 10.1089/wound.2023.0196. Epub 2024 Jun 3.
This study compared the effect of two frequencies of direct cold atmospheric plasma (direct-CAP) treatment with standard of care (SOC) alone on healing of venous leg ulcers (VLUs). Open-label, randomized controlled trial (ClinicalTrials.gov NCT04922463) on chronic VLUs at two home care organizations in the Netherlands. All three groups received SOC for 12 weeks or until healing. In addition, treatment groups received direct-CAP once (1× direct-CAP) or twice (2× direct-CAP) a week, at specialized wound care facilities and the patients' residences. Primary outcome was percentage of wounds healed. Secondary outcomes included wound area reduction and adverse events. In total, 46 patients were randomly allocated to receive SOC only ( = 15), SOC + direct-CAP once a week ( = 17), or SOC + direct-CAP twice a week ( = 14). A higher percentage of wounds healed within 12 weeks in the treatment groups 53.3% (1× direct-CAP, = 0.16) and 61.5% (2× direct-CAP, = 0.08) versus 25.0% (control). The largest wound area reduction was obtained with 2× direct-CAP (95.2%, = 0.07), followed by 1× direct-CAP (63.9%, = 0.58), versus control (52.8%). Absolute wound area reduced significantly compared with baseline in both treatment groups ( ≤ 0.001), not in control ( = 0.11). No device-related serious adverse events occurred. Direct-CAP applied once or twice a week could substantially improve wound healing of VLUs in primary care. Together with other clinical safety and efficacy data, these results support the integration of direct-CAP as a valuable therapy for complex wounds.
本研究比较了两种频率的直接冷大气等离子体（direct-CAP）治疗与单纯标准护理（SOC）对下肢静脉溃疡（VLU）愈合的影响。在荷兰的两个家庭护理机构对慢性VLU进行开放标签、随机对照试验（ClinicalTrials.gov NCT04922463）。所有三组均接受12周的SOC治疗或直至伤口愈合。此外，治疗组在专门的伤口护理机构和患者住所每周接受一次（1×direct-CAP）或两次（2×direct-CAP）direct-CAP治疗。主要结局是伤口愈合的百分比。次要结局包括伤口面积缩小和不良事件。总共46例患者被随机分配接受单纯SOC治疗（n = 15）、SOC + 每周一次direct-CAP治疗（n = 17）或SOC + 每周两次direct-CAP治疗（n = 14）。治疗组中，12周内愈合的伤口百分比更高，1×direct-CAP组为53.3%（P = 0.16），2×direct-CAP组为61.5%（P = 0.08），而对照组为25.0%。2×direct-CAP组的伤口面积缩小最大（95.2%，P = 0.07），其次是1×direct-CAP组（63.9%，P = 0.58），而对照组为52.8%。与基线相比，两个治疗组的绝对伤口面积均显著减小（P≤0.001），而对照组未减小（P = 0.11）。未发生与设备相关的严重不良事件。每周应用一次或两次direct-CAP可显著改善初级护理中VLU的伤口愈合。连同其他临床安全性和有效性数据，这些结果支持将direct-CAP作为复杂伤口的一种有价值的治疗方法纳入治疗方案。
