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Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma

NCT07656818 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-06-18

No results posted yet for this study

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).

Conditions

  • Chronic Subdural Hematoma
  • Subdural Hematoma
  • Recurrence
  • Postoperative Complications

Interventions

PROCEDURE

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.

DEVICE

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.

Sponsors & Collaborators

  • Centro Medico Issemym

    collaborator OTHER

  • Benjamín Gonzalo Rodríguez Méndez

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-02
Primary Completion
2027-02-28
Completion
2027-04-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07656818 on ClinicalTrials.gov