Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBenjamín Gonzalo Rodríguez Méndez

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

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Benjamín Gonzalo Rodríguez Méndez

Lead sponsor

National Institute of Nuclear Research - Mexico

Sponsor institution

Centro Medico Issemym

Collaborator