Clinical Research Directory
Browse clinical research sites, groups, and studies.
Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma
Sponsor: Benjamín Gonzalo Rodríguez Méndez
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).
Official title: Application of Non-Thermal Plasma in the Surgical Bed of Chronic Subdural Hematoma to Reduce the Post-Drainage Recurrence Rate: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-03-02
Completion Date
2027-04-30
Last Updated
2026-06-18
Healthy Volunteers
No
Interventions
Standard 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.
Non-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.
Locations (1)
Plasma Physics Laboratory, National Institute of Nuclear Research
Ocoyoacac, State of Mexico, Mexico