Clinical Trial

Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma

Recruiting
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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).
Trial Details
NCT Number NCT07656818
Lead Sponsor Benjamín Gonzalo Rodríguez Méndez
Collaborators: Centro Medico Issemym
Conditions Chronic Subdural Hematoma, Subdural Hematoma, Recurrence, Postoperative Complications
Enrollment 40 participants
Start Date 2026-03-02
Primary Completion 2027-02-28 (estimated)
Study Completion 2027-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-18