Cold (non-thermal) plasma to improve healing and reduce complications after thyroid removal
Official title: 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
Run by National Institute of Nuclear Research - Mexico · NCT07382973 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 26 (estimated) |
| Sponsor | National Institute of Nuclear Research - Mexico Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Ocoyoacac, State of Mexico) |
| Status | Recruiting |
| Started | August 20, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07382973 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
NIRAF-guided identification of parathyroids during thyroidectomy
A wearable near-infrared autofluorescence device is being tested to help surgeons find and protect the parathyroid glands during thyroid surgery in adults.
-
Can infrared thermography help predict how skin wounds heal after surgery?
This study tests if a harmless infrared camera can spot early signs of wound problems after skin surgery so clinicians can act sooner.
-
Lower leg skin grafts after tumour removal: does negative pressure dressings help or not?
This trial tests whether negative pressure wound therapy over split-thickness skin grafts on the lower leg reduces infection compared with traditional dressings in adults after skin tumour removal.
-
Postoperative outcomes after thyroidectomy: ERAS vs standard care
This study tests whether an enhanced recovery after surgery (ERAS) protocol helps adults 18–60 undergoing thyroidectomy recover faster and leave the hospital sooner compared with a local non-ERAS regimen.
-
Antibiotic Tissue Penetration in Head and Neck Infection and Reconstructive Surgery
This study tests how well common antibiotics reach head and neck tissue in adults with neck infections or during nasal reconstructive surgery using a flap.
-
Lactoferrin Gel for Healing and Implant Stability in Immediate Mandibular Molars
A 4% bovine lactoferrin nanohydrogel is being tested to see if it helps soft tissue and bone heal better and improve implant stability after immediate mandibular molar implants.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.