Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma
NCT: NCT07656818 · RECRUITING
Brief Summary
The goal of this randomized controlled trial is to evaluate whether the adjuvant application of non-thermal plasma (NTP) during standard surgical drainage of chronic subdural hematoma (cSDH) can reduce the recurrence rate at 6 months. The main questions it aims to answer are: * Does NTP application significantly lower the radiological and clinical recurrence rate of cSDH compared to surgery alone? * Is NTP safe when applied to the subdural space and surgical wound bed? * Does NTP improve functional outcomes and time to hematoma resolution? Participants will be randomly assigned to one of two groups: * Experimental group (n = 20): Standard burr hole drainage or craniotomy plus intraoperative NTP application over the exposed dura mater, the residual membrane, soft tissue layers, and the skin incision. * Control group (n = 20): Standard surgical drainage alone (no NTP). Follow-up includes clinical assessments and computed tomography (CT) scans at 1 week, 3 months, and 6 months post-surgery. The primary outcome is recurrence (symptomatic reaccumulation requiring re-intervention or ≥50% volume increase on CT).
Frequently Asked Questions
What is Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma?
Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma is a clinical trial registered under NCT07656818. Current status: RECRUITING.
What is the status of NCT07656818?
The current status of NCT07656818 (Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma) is: RECRUITING.
When did Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma start?
Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma started on 2026-03-02.
Related Devices
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.