Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma

NCT07656818 | Recruiting

• 1 other identifier: UEeIM.282/25
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Subdural Hematoma; Recurrence; Postoperative Complications; Chronic Subdural Hematoma

Keywords

Non-thermal plasma; Cold plasma; Chronic subdural hematoma; Neurosurgery; Recurrence prevention; Wound healing

Outcome Measures

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 (%).

  6 months post surgery

Secondary Outcomes (4)

• Time to Radiological Resolution

  From surgery to 6 months

• Change in Functional Status (Modified Rankin Scale)

  Baseline (pre-surgery) and at 6 months

• Incidence of Treatment Related Adverse Events

  From surgery to 6 months

• Glasgow Coma Scale (GCS) Improvement

  Baseline (pre-surgery) and at 6 months

Study Arms (2)

Standard Surgery Alone (Control)

ACTIVE COMPARATOR

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

Standard Surgery + Non-Thermal Plasma (NTP)

EXPERIMENTAL

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

Interventions

Standard Surgery Protocol PROCEDURE

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 Surgery Alone (Control)

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.

Also known as: Non Thermal Plasma (NTP) Application

Standard Surgery + Non-Thermal Plasma (NTP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Benjamín Gonzalo Rodríguez Méndez: lead
• Centro Medico Issemym: collaborator

Study Sites (1)

Plasma Physics Laboratory, National Institute of Nuclear Research

Ocoyoacac, State of Mexico, 52750, Mexico

RECRUITING

Related Publications (3)

• Lopez-Callejas R, Velasco-Garcia PS, Betancourt-Angeles M, Rodriguez-Mendez BG, Berrones-Stringel G, Jaramillo-Martinez C, Farias-Lopez FE, Mercado-Cabrera A, Valencia-Alvarado R. Use of Non-Thermal Plasma as Postoperative Therapy in Anal Fistula: Clinical Experience and Results. Biomedicines. 2024 Aug 15;12(8):1866. doi: 10.3390/biomedicines12081866.

  PMID: 39200330 BACKGROUND

• Martinez-Perez R, Tsimpas A, Rayo N, Cepeda S, Lagares A. Role of the patient comorbidity in the recurrence of chronic subdural hematomas. Neurosurg Rev. 2021 Apr;44(2):971-976. doi: 10.1007/s10143-020-01274-7. Epub 2020 Mar 7.

  PMID: 32146611 BACKGROUND

• McDonough R, Bechstein M, Fiehler J, Zanolini U, Rai H, Siddiqui A, Shotar E, Rouchaud A, Kallmes K, Goyal M, Gellissen S. Radiologic Evaluation Criteria for Chronic Subdural Hematomas: Recommendations for Clinical Trials. AJNR Am J Neuroradiol. 2022 Nov;43(11):1550-1558. doi: 10.3174/ajnr.A7503. Epub 2022 May 26.

  PMID: 35618427 BACKGROUND

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Hematoma, Subdural; Recurrence; Postoperative Complications

Condition Hierarchy (Ancestors)

Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Central Study Contacts

Régulo López-Callejas, PhD

CONTACT

+52 5553297200; regulo.lopez@inin.gob.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The neuroradiologist evaluating CT scans will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 18, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)