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.
Highlights
The use of phase-adapted wound dressings represents best practice (BP) in chronic wound treatment
Up to 5% of the general population in developed countries are affected by chronic wounds such as diabetic foot ulcers (DFU), venous leg ulcers (VLU), peripheral arterial occlusive disease (PAOD)-associated wounds and pressure ulcers (PU)[1–3]
Cold atmospheric plasma (CAP) is composed of free electrons and ions, electromagnetic fields, a certain amount of visible and ultraviolet light and infrared radiation as well as reactive oxygen species (ROS), nitric oxide (NO), hydrogen peroxide (H2O2), hydroxyl radicals (HO·) and atomic oxygen
Summary
The use of phase-adapted wound dressings represents best practice (BP) in chronic wound treatment. Treatment with the CAP-jet provides beneficial effects in chronic wound treatment regarding promotion of the wound healing process. Chronic wounds are linked to a high morbidity and impact on patients’ quality-of-life[5–7] The management of these wounds is often a major challenge in daily clinical practice. Local wound infections can result in a further healing delay and increase the risk of critical systemic infections[9]. Management of such infections requires a broad range of different wound dressings. Chronic wounds are susceptible for bacterial and fungi infections, which in turn can promote delayed wound healing and enhance the risk for the development of dangerous systemic infections[14,15] The physiological acidic pH value of the skin is essential for its complete functionality and resistance to noxae. Chronic wounds are often characterized by an alkaline milieu, impairing the physiological wound healing processes and promoting colonization with human-pathogenic b acteria[15]
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