← Back to all trials
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
Source: ClinicalTrials.gov (NCT07656818). StuddyBuddy aggregates publicly available trial information.