Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Trial Parameters
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Pregnancy or breastfeeding. * Concurrent use of systemic corticosteroids or immunosuppressive drugs that may impair wound healing.