RecruitingNot ApplicableNCT07656818

Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma

Application of Non-Thermal Plasma in the Surgical Bed of Chronic Subdural Hematoma to Reduce the Post-Drainage Recurrence Rate: A Randomized Controlled Trial

Sponsor

Benjamín Gonzalo Rodríguez Méndez

Enrollment

40 participants

Start Date

Mar 2, 2026

Study Type

INTERVENTIONAL

Conditions

Postoperative Complications Recurrence Subdural Hematoma Chronic Subdural Hematoma

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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria6

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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Interventions

PROCEDUREStandard Surgery Protocol

Standard burr hole drainage or craniotomy for chronic subdural hematoma, including complete evacuation of the collection and placement of a subdural drain if clinically indicated. No NTP is applied.

DEVICENon-Thermal Plasma

Standard surgical drainage as described above, followed by intraoperative application of non-thermal plasma (NTP) generated with helium gas (13.56 MHz RF generator, 20 Watts, flow 0.5 LPM). The plasma is applied sequentially and uniformly over: (i) the exposed dura mater and residual parietal membrane in the subdural space, (ii) the soft tissue layers during closure, and (iii) the skin incision after closure. Application time: approximately 60 seconds per 5 cm² area at a distance of 5 mm.