[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641148":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":36,"locations":43,"responsibleParty":63,"collaborators":67,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":35,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":35,"enrollmentInfo":79,"targetDuration":35,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":91,"overallStatus":46,"whyStopped":35,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"National Institute of Nuclear Research - Mexico","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Procedure: Standard Surgery Protocol",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Device: Non-Thermal Plasma",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],[27],"Standard Surgical Drainage",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"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.",[15],[34],"Non Thermal Plasma (NTP) Application",null,[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Régulo López-Callejas, PhD","CONTACT","+52 5553297200","12239","regulo.lopez@inin.gob.mx",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Plasma Physics Laboratory, National Institute of Nuclear Research","RECRUITING","Ocoyoacac","State of Mexico","52750","Mexico","MX",{"type":53,"coordinates":54},"Point",[55,56],-99.45787,19.27127,{"lat":56,"lon":55},[59],{"name":60,"role":39,"phone":40,"phoneExt":61,"email":62},"Diego Medina-Castro, PhD","12230","diego.medina@inin.gob.mx",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"SPONSOR_INVESTIGATOR","Benjamín Gonzalo Rodríguez Méndez","Principal Investigator",[68],{"name":69,"class":6},"Centro Medico Issemym","100641148","non-thermal-plasma-to-reduce-recurrence-in-chronic-subdural-hematoma-100641148",false,"NCT07656818","Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma","Application of Non-Thermal Plasma in the Surgical Bed of Chronic Subdural Hematoma to Reduce the Post-Drainage Recurrence Rate: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults ≥ 18 years of age\n* Diagnosis of symptomatic chronic subdural hematoma (cSDH) requiring surgical drainage (burr hole drainage or craniotomy)\n* Ability to provide written informed consent (or consent from legal representative if patient is incapacitated)\n\nExclusion Criteria:\n\n* Pure acute or subacute subdural hematoma\n* Uncontrolled coagulopathy or bleeding disorder\n* History of intracranial aneurysm or prior cerebrovascular event with residual deficit\n* Presence of active intracranial metallic implants or electronic devices (e.g., programmable shunt, cardiac pacemaker, deep brain stimulator) in the head region\n* Pregnancy or lactation\n* Participation in another interventional clinical trial within 30 days prior to screening","ALL","18 Years",{"count":80,"type":81},40,"ESTIMATED","INTERVENTIONAL",[84],"NA","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:\n\n* Does NTP application significantly lower the radiological and clinical recurrence rate of cSDH compared to surgery alone?\n* Is NTP safe when applied to the subdural space and surgical wound bed?\n* Does NTP improve functional outcomes and time to hematoma resolution?\n\nParticipants will be randomly assigned to one of two groups:\n\n* 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.\n* Control group (n = 20): Standard surgical drainage alone (no NTP).\n\nFollow-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).",[87,88,89,90],"Chronic Subdural Hematoma","Subdural Hematoma","Recurrence","Postoperative Complications",[92,93,94,95,96,97],"Non-thermal plasma","Cold plasma","Chronic subdural hematoma","Neurosurgery","Recurrence prevention","Wound healing","2026-06-16",{"date":100,"type":101},"2026-06-18","ACTUAL",{"date":103,"type":101},"2026-03-02",{"date":105,"type":81},"2027-04-30",{"name":65,"class":6},1]