Evaluation of Non-Thermal Plasma for Surgical Bed Decontamination and Tissue Recovery Acceleration Following Total Thyroidectomy

National Institute of Nuclear Research - Mexico

Status: Enrolling

Conditions: Thyroid Diseases; Wound Healing; Thyroidectomy; Surgical Wound Infection

Treatments: Other: Standard Surgical Wound Care Protocol; Device: Atmospheric Pressure Non-Thermal Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT07382973

CISEI-201/25

Details and patient eligibility

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).

Enrollment: 26 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups

Treatment with Non-Thermal Plasma (NTP)

Experimental group

Treatment:

Device: Atmospheric Pressure Non-Thermal Plasma

Standard Postoperative Care

Active Comparator group

Treatment:

Other: Standard Surgical Wound Care Protocol