The goal of this clinical trial is to evaluate the therapeutic efficacy and safety of non-thermal plasma (NTP) as an adjuvant treatment for surgical bed decontamination and accelerated tissue repair in patients undergoing total thyroidectomy. The study aims to address the following objectives:
* Does the intraoperative application of NTP to the surgical bed and closed incision promote accelerated tissue regeneration compared to conventional postoperative care? * Does NTP treatment reduce postoperative inflammatory response, pain intensity, and the incidence of site-specific complications (such as surgical site infection or seroma)? * What is the safety profile of helium-based NTP in the cervical anatomical region regarding neighboring neurovascular structures?
Participants will be randomized into two arms:
1. The experimental group: Receiving a standardized application of helium-based NTP (at a frequency of 13.56 MHz) to the surgical bed prior to closure and subsequently to the sutured incision. 2. The control group: Receiving standard-of-care surgical wound management.
Clinical follow-up will include quantitative assessment of healing rates, pain scales (VAS), and biochemical or clinical markers of inflammation at scheduled intervals (Days 1, 7, 15, and up to 12 weeks post-surgery).
Patients aged 18 years or older.
Diagnosis of thyroid pathology requiring total or subtotal thyroidectomy.
Signed Informed Consent Form (ICF).
Patients capable of complying with the 12-week follow-up schedule.
History of previous neck surgery or radiation therapy in the cervical area.
Known history of keloid formation or hypertrophic scarring.
Presence of active systemic or local infection at the time of surgery.
Patients with implanted electronic devices (e.g., pacemakers or defibrillators) due to the use of RF-based plasma.
Parallel
Atmospheric Pressure Non-Thermal Plasma
DeviceIntraoperative and postoperative application of non-thermal plasma (NTP) generated via a 13.56 MHz Radiofrequency (RF) generator at 20 Watts. High-purity helium gas will be used as the precursor at a flow rate of 0.5 LPM. The plasma jet will be applied directly to the surgical bed (pre-closure) and the sutured incision (post-closure), maintaining a distance of 1-3 mm from the tissue. The dosage is standardized at 1 minute per linear centimeter of the incision.
Standard Surgical Wound Care Protocol
Other interventionStandard surgical wound closure using conventional suturing techniques followed by the application of sterile dressings according to institutional protocols. No plasma treatment will be administered.
Time to complete wound re-epithelialization.
The number of days required for to achieve 100% skin closure of the surgical incision. Complete re-epithelialization is clinically defined as a fully closed wound without drainage, scabbing, or the need for dressings. Assessment will be performed by a blinded evaluator. Unit of measure: Days.
Postoperative pain intensity.
Patient-reported pain levels assessed using the Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents the worst imaginable pain. Unit of measure: VAS Score (0-10).
Incidence of surgical site complications.
Total number of participants experiencing at least one postoperative complication, specifically: surgical site infection (SSI), wound dehiscence, hematoma, or seroma formation, as confirmed by clinical diagnosis. Unit of measure: Number of participants.
Long-term scar quality assessment.
Objective evaluation of the scar using the Vancouver Scar Scale (VSS). The scale assesses four parameters: vascularity, pigmentation, pliability, and height. Total scores range from 0 to 13, with lower scores indicating better aesthetic and functional outcomes. Unit of measure: VSS Score (0-13).
Cumulative analgesic consumption.
Total amount of rescue analgesic medication (e.g., paracetamol or NSAIDs) required by the patient during the immediate postoperative period. This measure reflects the indirect impact of NTP on pain management. Unit of measure: Milligrams (mg) of medication.
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National Institute of Nuclear Research - Mexico
Lead sponsor
Centro Medico Issemym
Collaborator
