Study of Tolerance to the Application of Cold Plasma in the Treatment of Chronic Wounds

Condition(s) studied

Investigational drug(s) / intervention(s)

cold plasma treatment with helium 1min/10cm2: The plasma will be applied using the multi-jet probe by an investigating physician over the entire surface of the ulceration during the defined exposure times (1min/10 cm2), after which the nurse will apply the standard dressing appropriate for the characteristics of the ulceration. The sessions will be repeated daily for 8 days.

cold plasma treatment with helium 3min/10cm2: The plasma will be applied using the multi-jet probe by an investigating physician over the entire surface of the ulceration during the defined exposure times (3min/10 cm2), after which the nurse will apply the standard dressing appropriate for the characteristics of the ulceration.

dressings impregnated with ions induced by exposure to plasma: The plasma will be applied using the multi-jet probe by an investigating physician over the dressing, after which the nurse will apply the dressing on the ulceration.

Study summary

Chronic wounds affect many patients, with no downward trend in recent decades. This is a significant economic and social issue, and this condition has an impact on functional disabilities and quality of life, especially among the elderly. Diagnosis is essentially clinical, and there are many causes, but 90% of leg ulcers, for example, are primarily vascular in origin. There are wounds of traumatic, post-operative, and vascular origin, as well as pressure sores. The main purpose of invasive tests is to objectively determine the cause (arterial damage) or to check for underlying osteitis. Chronic wounds are usually infected or colonized by bacteria from the skin and digestive flora. There is no indication for antibiotic therapy in the treatment of wounds. Nursing staff play an important role in therapeutic management, which must be carried out in harmony with other healthcare professionals, such as general practitioners and specialists. This management has two main goals: to accelerate the epidermalization of chronic wounds, or even their healing, and to limit local and general complications, the recurrence of which remains the most difficult to control. There are many types of healing dressings available, adapted to each type of ulceration: fibrinous, necrotic, superinfected, etc.

Nevertheless, innovative solutions can accelerate healing, thereby reducing hospital stays, disabilities associated with chronic wounds, and complications such as skin-related septicemia. Research efforts may focus on the use of growth factors, for example, for old or stubborn forms of the disease, despite proper medical treatment, or on any other innovative technique.

The properties of cold plasma appear to be suitable for the treatment of chronic wounds, as has been demonstrated in cell models, animal models, and with argon plasma in several countries around the world on an experimental basis in humans.

The GREMI in Orléans has acquired internationally recognized expertise in the technique of cold helium plasma. The combination of this applied research laboratory and the Infectious Diseases Department of the Orléans University Hospital has led to the development of relationships that have resulted in the proposal to conduct this study, based in its first phase on the evaluation of the medical device's tolerance.

Eligibility

Primary outcome measure(s)

• Level of local inflammation — Everyday for 8 days

Trial sites (1)

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