Evaluating Non-Thermal Plasma as an Addition to Standard Surgery for Chronic Subdural Hematoma to Reduce Recurrence

What this Trial Is About

Researchers are evaluating the use of non-thermal plasma NTP as an additional treatment during standard surgical drainage for adults with symptomatic chronic subdural hematoma cSDH. This randomized controlled trial aims to determine if applying NTP during surgery can reduce the recurrence rate of cSDH within six months, assess the safety of NTP in the surgical area, and evaluate its effects on functional recovery and the speed of hematoma resolution. Participants undergo either standard surgery alone or standard surgery combined with intraoperative NTP application. The NTP is generated by a device using helium gas and applied sequentially to the exposed dura mater, residual membranes, soft tissue layers, and skin incision during surgery. Both groups receive the same standard perioperative care, including antibiotics and pain management. Follow-up visits occur at one week, three months, and six months post-surgery. During follow-up, clinical assessments include neurological scales such as the Glasgow Coma Scale and Modified Rankin Scale, along with head CT scans to monitor hematoma status. The main outcome measured is recurrence of the hematoma, defined by symptoms requiring re-intervention or significant volume increase on CT. Secondary outcomes include time to radiological resolution, changes in functional status, and safety through adverse event monitoring. Participation lasts for six months post-surgery.

Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma