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

NCT07382973 | Recruiting

• 1 other identifier: CISEI-201/25
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Thyroid Diseases; Wound Healing; Thyroidectomy; Surgical Wound Infection

Keywords

Non-Thermal Plasma; Cold Plasma; Thyroid Surgery; Wound Healing; Postoperative Pain; Adjuvant Therapy; Surgical Bed Decontamination

Outcome Measures

Primary Outcomes (1)

• 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.

  From day 0 (day of surgery) up to day 21.

Secondary Outcomes (4)

• Postoperative pain intensity.

  At 2, 12, 24, 36, 48, and 72 hours, and on days 7 and 14 post-surgery.

• Incidence of surgical site complications.

  From surgery through 28 days post-surgery.

• Long-term scar quality assessment.

  At 12 weeks post-surgery.

• Cumulative analgesic consumption.

  First 48 hours post-surgery.

Study Arms (2)

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).

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.

Other: Standard Surgical Wound Care Protocol

Interventions

Atmospheric Pressure Non-Thermal Plasma DEVICE

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.

Treatment with Non-Thermal Plasma (NTP)

Standard Surgical Wound Care Protocol OTHER

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.

Standard Postoperative Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Nuclear Research - Mexico: lead
• Centro Medico Issemym: collaborator

Study Sites (1)

Plasma Physics Laboratory, National Institute of Nuclear Research

Ocoyoacac, State of Mexico, 52750, Mexico

RECRUITING

Related Publications (2)

• 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.

  PMID: 29348977 BACKGROUND

• Rodriguez-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.

  PMID: 38256546 BACKGROUND

MeSH Terms

Conditions

Thyroid Diseases; Surgical Wound Infection; Pain, Postoperative

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

López-Callejas, PhD

CONTACT

+52 5553297200; regulo.lopez@inin.gob.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: August 20, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)