全甲状腺摘出術後の手術部位除染および組織回復促進のための非熱プラズマの評価
甲状腺手術患者における術後創傷治療の最適化のための革新的戦略としての非熱プラズマの評価：倫理的および臨床的アプローチ
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).
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：López-Callejas, PhD
- 電話番号：12239 +52 5553297200
- メール：regulo.lopez@inin.gob.mx
研究場所
-
-
State of Mexico
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Ocoyoacac、State of Mexico、メキシコ、52750
- 募集
- Plasma Physics Laboratory, National Institute of Nuclear Research
-
コンタクト：
- Medina-Castro, PhD
- 電話番号：12230 +52 5553297200
- メール：diego.medina@inin.gob.mx
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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). |
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. |
|
アクティブコンパレータ：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. |
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. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to complete wound re-epithelialization.
時間枠：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. |
From day 0 (day of surgery) up to day 21.
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative pain intensity.
時間枠：At 2, 12, 24, 36, 48, and 72 hours, and on days 7 and 14 post-surgery.
|
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). |
At 2, 12, 24, 36, 48, and 72 hours, and on days 7 and 14 post-surgery.
|
|
Incidence of surgical site complications.
時間枠：From surgery through 28 days post-surgery.
|
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. |
From surgery through 28 days post-surgery.
|
|
Long-term scar quality assessment.
時間枠：At 12 weeks post-surgery.
|
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). |
At 12 weeks post-surgery.
|
|
Cumulative analgesic consumption.
時間枠：First 48 hours post-surgery.
|
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. |
First 48 hours post-surgery.
|
協力者と研究者
協力者
協力者
出版物と役立つリンク
一般刊行物
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- CISEI-201/25
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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