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

RecruitingNAAges 18 Years - anyAllNational Institute of Nuclear Research - Mexico
NCT07382973 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Atmospheric Pressure Non-Thermal Plasma
  • Standard Surgical Wound Care Protocol
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Where

1 site
Plasma Physics Laboratory, National Institute of Nuclear Research
Ocoyoacac, Mexico
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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