Thyroid DiseasesNCT07382973
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
A study testing Atmospheric Pressure Non-Thermal Plasma and Standard Surgical Wound Care Protocol in people with Thyroid Diseases and Wound Healing, run by National Institute of Nuclear Research - Mexico at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Diseases, Wound Healing, Thyroidectomy
- What is being tested?
- Atmospheric Pressure Non-Thermal Plasma and Standard Surgical Wound Care Protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteMexico
- Study dates
- 20 Aug 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Plasma Physics Laboratory, National Institute of Nuclear Research
Ocoyoacac, State of Mexico, 52750
Medina-Castro, PhD, +52 5553297200 ext. 12230, diego.medina@inin.gob.mx
About this study
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
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?
Read more
Participants will be randomized into two arms:
- 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.
- 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).
Read the detailed description
This prospective study addresses the two most critical limitations of conventional thyroid surgery: collateral thermal damage to noble structures and the risk of microscopic residual disease in incidental carcinoma cases.
The investigation focuses on the application of non-thermal plasma (NTP), a state of matter that generates a controlled 'cocktail' of Reactive Oxygen and Nitrogen Species (RONS). Unlike conventional energy-based devices (laser or electrocautery), NTP operates at low temperatures, eliminating lateral thermal dispersion and carbonization, thus preserving the functional integrity of the recurrent laryngeal nerve and parathyroid glands.
The standardized NTP protocol is executed in two distinct phases:
- Phase I (Hemostasis and Neuroprotection): Following thyroid gland resection, the surgical bed is exposed to a power density of 0.5 W/cm² for 8-10 minutes. This phase targets the carotid sheath and the tracheoesophageal groove to ensure immediate hemostasis and to modulate the inflammatory response through redox signaling, thereby preventing exuberant fibroplasia.
- Phase II (Selective Oncological Ablation): In cases where incidental malignancy is suspected or confirmed, an additional re-exposure of 10-12 minutes is performed specifically on the resection micro-margins. This phase leverages the selective cytotoxicity of RONS, which induces mitochondrial dysfunction and apoptosis in neoplastic cells while sparing healthy surrounding tissue.
The study aims to correlate this two-phase intervention with three primary clinical pillars: a) Absolute surgical safety (0% complication rate in nerve paralysis and hypocalcemia). b) Oncological sterilization (undetectable Thyroglobulin levels <0.1 ng/dL at 6 months). c) High-fidelity tissue mimicry (evaluated via VSS and POSAS scales), hypothesizing that NTP-mediated redox modulation achieves superior cosmetic and functional outcomes compared to traditional photobiomodulation.
- Being tested
- Atmospheric Pressure Non-Thermal Plasma, Standard Surgical Wound Care Protocol
- Keywords
- Non-Thermal Plasma, Cold Plasma, Thyroid Surgery, Wound Healing, Postoperative Pain, Adjuvant Therapy, Surgical Bed Decontamination
- Medical subject headings
- Thyroid Diseases, Surgical Wound Infection, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atmospheric Pressure Non-Thermal PlasmaDevice
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.
Standard Surgical Wound Care ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Non-Thermal Plasma (NTP) | Experimental | The single experimental arm consists of patients undergoing total or partial thyroidectomy who receive a standardised treatment with Non-Thermal Plasma (NTP). This group is evaluated for surgical safety (nerve preservation/hemostasis) and oncological efficacy (residual disease control). Receives: Device: Atmospheric Pressure Non-Thermal Plasma |
| Standard Postoperative Care | Active comparator | Participants randomized to this arm will receive the institution's current standard postoperative wound care following thyroid surgery. This includes routine surgical wound closure (sutures/staples) and standard dressing, without any application of non-thermal plasma. All other aspects of perioperative care, including pain management and follow-up visits, will follow standard institutional protocols. Receives: Other: Standard Surgical Wound Care Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete wound re-epithelialization.
The number of days required for to achieve 100% skin closure of the surgical incision. Complete re-epithelialization is clinically defined as a fully closed wound without drainage, scabbing, or the need for dressings. Assessment will be performed by a blinded evaluator. Unit of measure: Days.
Measured: From day 0 (day of surgery) up to day 21.
Secondary outcomes (4)
Postoperative pain intensity.
Patient-reported pain levels assessed using the Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents the worst imaginable pain. Unit of measure: VAS Score (0-10).
Measured: At 2, 12, 24, 36, 48, and 72 hours, and on days 7 and 14 post-surgery.
Incidence of surgical site complications.
Total number of participants experiencing at least one postoperative complication, specifically: surgical site infection (SSI), wound dehiscence, hematoma, or seroma formation, as confirmed by clinical diagnosis. Unit of measure: Number of participants.
Measured: From surgery through 28 days post-surgery.
Long-term scar quality assessment.
Objective evaluation of the scar using the Vancouver Scar Scale (VSS). The scale assesses four parameters: vascularity, pigmentation, pliability, and height. Total scores range from 0 to 13, with lower scores indicating better aesthetic and functional outcomes. Unit of measure: VSS Score (0-13).
Measured: At 12 weeks post-surgery.
Cumulative analgesic consumption.
Total amount of rescue analgesic medication (e.g., paracetamol or NSAIDs) required by the patient during the immediate postoperative period. This measure reflects the indirect impact of NTP on pain management. Unit of measure: Milligrams (mg) of medication.
Measured: First 48 hours post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start20 Aug 2025
- Primary completion30 Sep 2026
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thyroid DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Nuclear Research - Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Medico Issemym
- Responsible party
- Principal investigator, Benjamín Gonzalo Rodríguez Méndez, National Institute of Nuclear Research - Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382973
- Sponsor's protocol ID
- CISEI-201/25
- Status last verified
- Nov 2026
- First submitted
- 26 Jan 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Betancourt-Angeles M, Pena-Eguiluz R, Lopez-Callejas R, Dominguez-Cadena NA, Mercado-Cabrera A, Munoz-Infante J, Rodriguez-Mendez BG, Valencia-Alvarado R, Moreno-Tapia JA. Treatment in the healing of burns with a cold plasma source. Int J Burns Trauma. 2017 Dec 20;7(7):142-146. eCollection 2017.
PubMed 29348977Rodriguez-Mendez BG, Lopez-Callejas R, Mercado-Cabrera A, Pena-Eguiluz R, Valencia-Alvarado R, Betancourt-Angeles M, Berrones-Stringel G, Jaramillo-Martinez C. Harnessing Non-Thermal Plasma to Supercharge Recovery in Abdominal Surgeries: A Pilot Study. J Clin Med. 2024 Jan 11;13(2):408. doi: 10.3390/jcm13020408.
PubMed 38256546
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07382973
- Acronym / sponsor ID
- CISEI-201/25
- Keywords
- Non-Thermal Plasma, Cold Plasma, Thyroid Surgery, Wound Healing, Postoperative Pain, Adjuvant Therapy, Surgical Bed Decontamination
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- National Institute of Nuclear Research - MexicoUniversity, hospital or other
- Collaborators
- Centro Medico Issemym
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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).
Detailed description
This prospective study addresses the two most critical limitations of conventional thyroid surgery: collateral thermal damage to noble structures and the risk of microscopic residual disease in incidental carcinoma cases.
The investigation focuses on the application of non-thermal plasma (NTP), a state of matter that generates a controlled 'cocktail' of Reactive Oxygen and Nitrogen Species (RONS). Unlike conventional energy-based devices (laser or electrocautery), NTP operates at low temperatures, eliminating lateral thermal dispersion and carbonization, thus preserving the functional integrity of the recurrent laryngeal nerve and parathyroid glands.
The standardized NTP protocol is executed in two distinct phases:
- Phase I (Hemostasis and Neuroprotection): Following thyroid gland resection, the surgical bed is exposed to a power density of 0.5 W/cm² for 8-10 minutes. This phase targets the carotid sheath and the tracheoesophageal groove to ensure immediate hemostasis and to modulate the inflammatory response through redox signaling, thereby preventing exuberant fibroplasia.
- Phase II (Selective Oncological Ablation): In cases where incidental malignancy is suspected or confirmed, an additional re-exposure of 10-12 minutes is performed specifically on the resection micro-margins. This phase leverages the selective cytotoxicity of RONS, which induces mitochondrial dysfunction and apoptosis in neoplastic cells while sparing healthy surrounding tissue.
The study aims to correlate this two-phase intervention with three primary clinical pillars: a) Absolute surgical safety (0% complication rate in nerve paralysis and hypocalcemia). b) Oncological sterilization (undetectable Thyroglobulin levels <0.1 ng/dL at 6 months). c) High-fidelity tissue mimicry (evaluated via VSS and POSAS scales), hypothesizing that NTP-mediated redox modulation achieves superior cosmetic and functional outcomes compared to traditional photobiomodulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with Non-Thermal Plasma (NTP) | Experimental | Device: Atmospheric Pressure Non-Thermal PlasmaThe single experimental arm consists of patients undergoing total or partial thyroidectomy who receive a standardised treatment with Non-Thermal Plasma (NTP). This group is evaluated for surgical safety (nerve preservation/hemostasis) and oncological efficacy (residual disease control). |
| Standard Postoperative Care | Active comparator | Other: Standard Surgical Wound Care ProtocolParticipants randomized to this arm will receive the institution's current standard postoperative wound care following thyroid surgery. This includes routine surgical wound closure (sutures/staples) and standard dressing, without any application of non-thermal plasma. All other aspects of perioperative care, including pain management and follow-up visits, will follow standard institutional protocols. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atmospheric Pressure Non-Thermal PlasmaIntraoperative 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. | Device | Treatment with Non-Thermal Plasma (NTP) |
| Standard Surgical Wound Care ProtocolStandard surgical wound closure using conventional suturing techniques followed by the application of sterile dressings according to institutional protocols. No plasma treatment will be administered. | Other | Standard Postoperative Care |
Primary outcome
Time to complete wound re-epithelialization.
Time frame: From day 0 (day of surgery) up to day 21.
The number of days required for to achieve 100% skin closure of the surgical incision. Complete re-epithelialization is clinically defined as a fully closed wound without drainage, scabbing, or the need for dressings. Assessment will be performed by a blinded evaluator. Unit of measure: Days.
4 secondary outcomes
Postoperative pain intensity.
Time frame: At 2, 12, 24, 36, 48, and 72 hours, and on days 7 and 14 post-surgery.
Incidence of surgical site complications.
Time frame: From surgery through 28 days post-surgery.
Long-term scar quality assessment.
Time frame: At 12 weeks post-surgery.
Cumulative analgesic consumption.
Time frame: First 48 hours post-surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 29348977Betancourt-Angeles M, Pena-Eguiluz R, Lopez-Callejas R, Dominguez-Cadena NA, Mercado-Cabrera A, Munoz-Infante J, Rodriguez-Mendez BG, Valencia-Alvarado R, Moreno-Tapia JA. Treatment in the healing of burns with a cold plasma source. Int J Burns Trauma. 2017 Dec 20;7(7):142-146. eCollection 2017.
- Background: PubMed 38256546Rodriguez-Mendez BG, Lopez-Callejas R, Mercado-Cabrera A, Pena-Eguiluz R, Valencia-Alvarado R, Betancourt-Angeles M, Berrones-Stringel G, Jaramillo-Martinez C. Harnessing Non-Thermal Plasma to Supercharge Recovery in Abdominal Surgeries: A Pilot Study. J Clin Med. 2024 Jan 11;13(2):408. doi: 10.3390/jcm13020408.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atmospheric Pressure Non-Thermal Plasma and Standard Surgical Wound Care Protocol in people with Thyroid Diseases and Wound Healing, run by National Institute of Nuclear Research - Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact López-Callejas, PhD (+52 5553297200 ext. 12239, regulo.lopez@inin.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete wound re-epithelialization. (time frame: From day 0 (day of surgery) up to day 21.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07382973, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.