Tolerance Study of Cold Helium Plasma Treatment for Chronic Wounds and Ulcers

What this Trial Is About

Chronic wounds, such as leg ulcers primarily caused by vascular issues, have not decreased in recent decades and significantly affect patients quality of life and physical abilities, especially among the elderly. These wounds can also arise from trauma, surgery, or pressure sores and are typically colonized by bacteria, though antibiotics are not used for treatment. The study aims to evaluate the tolerance of a medical device using cold helium plasma, a promising innovative technique, in managing chronic wounds and accelerating their healing process while reducing complications. Participants will be randomly assigned to one of four groups two receive cold plasma treatment with helium applied for either 1 minute or 3 minutes per 10 cm of the wound surface daily for eight days, one group receives dressings impregnated with ions induced by plasma exposure, and one group receives conventional treatment with hydrocolloid or other appropriate dressings. The plasma treatments are administered by a physician using a multi-jet probe, and nurses apply the dressings suited to the ulcers characteristics after plasma exposure. During the study, participants will have their wounds monitored daily over eight days to assess local inflammation levels and changes in ulcer size and tissue loss. Bacterial load will be semi-quantitatively measured at the start and end of treatment. The research team will track these outcomes to evaluate the devices tolerance and potential effects. The study involves close follow-up with standard dressing care alongside the plasma treatments or conventional care, aiming to improve healing and reduce complications.

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