Thyroidectomy Clinical Trials

Clinical trials related to Thyroidectomy Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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: 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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Mexico
Plasma Physics Laboratory, National Institute of Nuclear Research
RECRUITING
Ocoyoacac
Contact Information
Primary
López-Callejas, PhD
regulo.lopez@inin.gob.mx
+52 5553297200
Time Frame
Start Date: 2025-08-20
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 26
Treatments
Experimental: Treatment with Non-Thermal Plasma (NTP)
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).
Active_comparator: Standard Postoperative Care
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.
Related Therapeutic Areas
Sponsors
Leads: National Institute of Nuclear Research - Mexico
Collaborators: Centro Medico Issemym

This content was sourced from clinicaltrials.gov