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Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma

ConditionsChronic Subdural HematomaSubdural HematomaRecurrencePostoperative Complications
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBenjamín Gonzalo Rodríguez Méndez

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Surgery Protocol

    Procedure/Surgery

    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

    Device

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Standard Surgery Alone (Control)Active comparator 1 intervention
Group B: Standard Surgery + Non-Thermal Plasma (NTP)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Benjamín Gonzalo Rodríguez Méndez

Lead sponsor

National Institute of Nuclear Research - Mexico

Sponsor institution

Centro Medico Issemym

Collaborator

Source ClinicalTrials.gov
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