Non-Thermal Plasma Used During Surgery to Help Prevent Recurrent Chronic Subdural Hematoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, randomized, parallel-group study compares standard surgical drainage to the same surgery with intraoperative non-thermal plasma (NTP) application. Patients with symptomatic chronic subdural hematoma needing drainage are assigned 1:1 to receive NTP on exposed dura, residual membrane, and surrounding tissues, or no NTP. The trial includes CT and clinical follow-ups at 1 week, 3 months, and 6 months to assess recurrence, safety, and functional outcomes. It is conducted at ISSEMYM Medical Centre Toluca (with ININ collaboration) to explore whether NTP can modulate the subdural environment and reduce recurrent hematoma.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* Pregnancy or lactation
* Participation in another interventional clinical trial within 30 days prior to screening

Where it's running

• Plasma Physics Laboratory, National Institute of Nuclear Research
  Ocoyoacac, State of Mexico, Mexico Recruiting

Study contacts

• Study coordinator: Régulo López-Callejas, PhD
• Email: regulo.lopez@inin.gob.mx
• Phone: +52 5553297200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.