Cold (non-thermal) plasma to improve healing and reduce complications after thyroid removal
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
This will test whether applying helium-based non-thermal (cold) plasma during total thyroidectomy helps wounds heal faster and reduces pain, inflammation, and infections in adults having their thyroid removed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institute of Nuclear Research - Mexico Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Ocoyoacac, State of Mexico) |
| Trial ID | NCT07382973 on ClinicalTrials.gov |
What this trial studies
This randomized interventional pilot compares intraoperative helium-based non-thermal plasma (NTP) plus standard wound care versus standard wound care alone in adults undergoing total or subtotal thyroidectomy. The NTP protocol is applied in two phases: an 8–10 minute exposure to the surgical bed for hemostasis and neuroprotection, with an additional 10–12 minute exposure to resection micro-margins when incidental malignancy is suspected. The device generates reactive oxygen and nitrogen species (RONS) at low temperature to promote decontamination and tissue repair while minimizing thermal damage to nerves and parathyroid glands. Participants are followed for 12 weeks to track wound healing, pain, infections, and safety outcomes related to cervical neurovascular structures.
Who should consider this trial
Good fit: Adults aged 18 or older scheduled for total or subtotal thyroidectomy who can attend a 12-week follow-up and who have no prior neck surgery or radiation, no implanted electronic devices, are not pregnant or breastfeeding, and are not on systemic immunosuppressants.
Not a fit: Patients with prior neck surgery or radiation, active infection, keloid-prone scarring, implanted pacemakers/defibrillators, pregnancy, breastfeeding, or current systemic corticosteroid/immunosuppressive use are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, NTP could lower postoperative wound complications, reduce pain and inflammation, and selectively reduce microscopic residual tumor without causing thermal injury to nearby nerves or glands.
How similar studies have performed: Preclinical work and early clinical reports suggest NTP can aid wound decontamination and healing, but its intraoperative use as an adjuvant in thyroid surgery is novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ocoyoacac, State of Mexico
- Plasma Physics Laboratory, National Institute of Nuclear Research — Ocoyoacac, State of Mexico, Mexico (Recruiting)
Study contacts
- Study coordinator: López-Callejas, PhD
- Email: regulo.lopez@inin.gob.mx
- Phone: +52 5553297200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.