About this trial
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).
Eligibility criteria
Qualifiers
Adults ≥ 18 years of age
Diagnosis of symptomatic chronic subdural hematoma (cSDH) requiring surgical drainage (burr hole drainage or craniotomy)
Ability to provide written informed consent (or consent from legal representative if patient is incapacitated)
Disqualifiers
Pure acute or subacute subdural hematoma
Uncontrolled coagulopathy or bleeding disorder
History of intracranial aneurysm or prior cerebrovascular event with residual deficit
Presence of active intracranial metallic implants or electronic devices (e.g., programmable shunt, cardiac pacemaker, deep brain stimulator) in the head region
Trial design
Treatments tested in this trial
- Standard Surgery Protocol
- Non-Thermal Plasma
Treatment groups
Sponsors and collaborators
Benjamín Gonzalo Rodríguez Méndez
Lead sponsor
National Institute of Nuclear Research - Mexico
Sponsor institution
Centro Medico Issemym
Collaborator