RECRUITINGINTERVENTIONAL

Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control

Evaluation of Non-Thermal Plasma as an Innovative Strategy for Optimizing Post-Surgical Wound Treatment in Patients of Thyroid Surgery: An Ethical and Clinical Approach

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - Patients aged 18 years or older. - Diagnosis of thyroid pathology requiring total or subtotal thyroidectomy. - Signed willing to sign a consent form Form (ICF). - Patients capable of complying with the 12-week follow-up schedule. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DEVICE

Atmospheric Pressure Non-Thermal Plasma

Intraoperative 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.

OTHER

Standard Surgical Wound Care Protocol

Standard surgical wound closure using conventional suturing techniques followed by the application of sterile dressings according to institutional protocols. No plasma treatment will be administered.

Locations (1)

Plasma Physics Laboratory, National Institute of Nuclear Research

Ocoyoacac, State of Mexico, Mexico