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Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma

RecruitingNAAges 18 Years - anyAllBenjamín Gonzalo Rodríguez Méndez
NCT07656818 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 includ

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📋 Eligibility rules (as published)
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
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What it tests

  • Standard Surgery Protocol
  • Non-Thermal Plasma
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Where

1 site
Plasma Physics Laboratory, National Institute of Nuclear Research
Ocoyoacac, Mexico
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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