An interventional study of Standard Surgery Protocol and Non-Thermal Plasma in Chronic Subdural Hematoma, Subdural Hematoma and Recurrence, sponsored by Benjamín Gonzalo Rodríguez Méndez. Recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Benjamín Gonzalo Rodríguez Méndez · Not applicable, Interventional, and Treatment
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:
Participants will be randomly assigned to one of two groups:
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).
This is a prospective, randomised, controlled, parallel-group trial conducted at the ISSEMYM Medical Centre Toluca, "Lic. Arturo Montiel Rojas" (Metepec, State of Mexico, Mexico), in collaboration with the National Institute of Nuclear Research (ININ, Ocoyoacac, State of Mexico, Mexico). The study aims to evaluate the efficacy and safety of intraoperative non-thermal plasma (NTP) application as an adjunct to standard surgical drainage for chronic subdural hematoma (cSDH).
The pathophysiology of cSDH recurrence is driven by the residual vascular parietal membrane (neomembrane), which maintains chronic inflammation, fragile neoangiogenesis, and recurrent microhemorrhages. Standard burr hole drainage or craniotomy evacuates the liquid collection but does not neutralise this biological substrate. Preclinical and clinical evidence suggest that NTP, through controlled delivery of reactive oxygen and nitrogen species (RONS), exerts local anti-inflammatory and pro-regenerative effects. Therefore, NTP applied directly to the subdural space and surgical wound bed may modulate the pathological membrane and reduce recurrence rates.
Eligible patients (≥18 years) with symptomatic cSDH requiring surgery will be randomised 1:1 to either the control group (standard surgery alone) or the experimental group (standard surgery + NTP). Randomisation will be performed using a computer-generated sequence with sealed opaque envelopes. The treating neurosurgeon cannot be blinded due to the nature of the intervention, but the neuroradiologist assessing follow-up CT scans will be blinded to group allocation.
The NTP device (13.56 MHz RF generator, 20 Watts, helium gas at 0.5 LPM) will be operated by trained biomedical personnel from ININ under direct neurosurgical supervision. Application protocol:
The control group receives identical surgical treatment without NTP. Both groups receive standard perioperative care, including antibiotics and pain management as per institutional protocol.
Follow-up visits are scheduled at 1 week (± 2 days), 3 months (± 2 weeks), and 6 months (± 2 weeks) post-surgery. At each visit, the clinical assessment includes the Glasgow Coma Scale (GCS), the Modified Rankin Scale (mRS), and documentation of any adverse events. Non-contrast head CT scans are performed at all three time points. The primary endpoint - recurrence - is defined as symptomatic reaccumulation requiring surgical re-intervention OR an asymptomatic volume increase ≥50% on CT scan. Secondary endpoints include time to ≥50% radiological resolution, change in mRS, and safety (adverse events).
The protocol has been approved by the Health Research and Research Ethics Committee (approval number UEeIM.282/25). Written informed consent will be obtained from all participants or their legal representatives. The study is conducted in accordance with the Declaration of Helsinki and Mexican health regulations. Data confidentiality is maintained through coding and secure storage. Participants may withdraw at any time without affecting their medical care. ININ provides the NTP equipment, gas, and technical personnel. ISSEMYM provides surgical resources, hospital facilities, and clinical follow-up. No commercial funding is involved. Results will be disseminated via peer-reviewed publications and scientific conferences, regardless of the outcome.
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's planned enrollment of 40 is below the median of 185 across 86 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →Benjamín Gonzalo Rodríguez Méndez is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomised to this arm will receive standard surgical drainage for chronic subdural hematoma according to the routine protocol at ISSEMYM Medical Centre, Toluca. The procedure consists of burr hole drainage or craniotomy under general anaesthesia, complete evacuation of the subdural fluid collection, and placement of a subdural drain if the surgeon considers it necessary. The wound is then closed in anatomical layers. No non-thermal plasma or any other experimental intervention is applied. All participants receive standard perioperative care, including prophylactic antibiotics, pain management, and early mobilisation as per institutional guidelines. Follow-up includes clinical assessments and CT scans at 1 week, 3 months, and 6 months.
Procedure: Standard Surgery Protocol
Participants randomised to this arm will receive the same standard surgical drainage procedure as described for the control arm. After evacuation of the hematoma and before wound closure, non-thermal plasma (NTP) is applied sequentially and uniformly to the surgical bed. The NTP is generated by a 13.56 MHz radiofrequency generator at 20 Watts using helium gas at 0.5 LPM. Application parameters: 60 seconds per 5 cm², nozzle-to-tissue distance of 5 mm. The plasma is applied in the following order: (1) over the exposed dura mater and any visible residual parietal membrane in the subdural space; (2) over the soft tissue layers (subcutaneous tissue) during the layered closure; and (3) over the skin incision after final closure. The total time for the NTP application is approximately 3-5 minutes. After the NTP application, wound closure is completed. All other aspects of perioperative care (antibiotics, pain management, follow-up schedule) are identical to the control arm.
Device: Non-Thermal Plasma
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.
Also known as: Standard Surgical Drainage
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.
Also known as: Non Thermal Plasma (NTP) Application
Recurrence Rate of Chronic Subdural Hematoma
Proportion of participants with radiological or clinical recurrence, defined as symptomatic re-accumulation requiring surgical re-intervention OR an asymptomatic volume increase ≥50% on CT scan. Unit of Measure: Percentage (%).
Time frame: 6 months post surgery
Time to Radiological Resolution
Number of days from surgery until ≥50% reduction in hematoma volume on CT scan. Unit of Measure: Days.
Time frame: From surgery to 6 months
Change in Functional Status (Modified Rankin Scale)
Modified Rankin Scale (mRS) score ranging from 0 (no symptoms) to 6 (death). A lower score indicates better functional outcome. Unit of Measure: mRS score (0-6).
Time frame: Baseline (pre-surgery) and at 6 months
Incidence of Treatment Related Adverse Events
Number of participants with local adverse events (thermal injury, wound infection, dehiscence) or neurological complications (seizure, new deficit) possibly related to NTP or the surgical procedure. Unit of Measure: Number of participants.
Time frame: From surgery to 6 months
Glasgow Coma Scale (GCS) Improvement
Change in Glasgow Coma Scale score (3-15, where 15 indicates full alertness and 3 indicates deep unconsciousness or coma). Unit of Measure: GCS points.
Time frame: Baseline (pre-surgery) and at 6 months
Plan to share: No
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Benjamín Gonzalo Rodríguez Méndez