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.
National Institute of Nuclear Research - Mexico
Lead sponsor
Centro Medico Issemym
Collaborator