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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Time to complete wound re-epithelialization.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Atmospheric Pressure Non-Thermal Plasma (Device)
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.
干预措施: Standard Surgical Wound Care Protocol (Other)
结局指标
主要结局
Time to complete wound re-epithelialization.
时间窗: 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.
次要结局
- 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.)
研究者
Benjamín Gonzalo Rodríguez Méndez
Principal Investigator
National Institute of Nuclear Research - Mexico