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Recruiting NCT07656818

Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma

Conditions: Chronic Subdural Hematoma, Subdural Hematoma, Recurrence, Postoperative Complications

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Benjamín Gonzalo Rodríguez Méndez

Location: Plasma Physics Laboratory, National Institute of Nuclear Research Ocoyoacac State of Mexico

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).

Eligibility Criteria

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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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07656818). StuddyBuddy aggregates publicly available trial information.