Actively Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Led by National Institute of Nuclear Research - Mexico · Updated on 2026-02-09
26
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
Sponsors
N
National Institute of Nuclear Research - Mexico
Lead Sponsor
C
Centro Medico Issemym
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Plasma Physics Laboratory, National Institute of Nuclear Research
Ocoyoacac, State of Mexico, Mexico, 52750
Actively Recruiting
Research Team
L
López-Callejas, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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