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<p>A novel patent chest-strap was developed for use in endoscopic transaxillary thyroid surgery. We conducted a phase prospective study in China to evaluate its utility and safety. This phase 1 study evaluates the utility, safety, and effectiveness of a novel patent chest-strap in a real-world clinical patient population. This single-center, open-label, prospective, randomized study was conducted from July 1, 2025, to March 31, 2026, to evaluate the long-term safety and efficacy of a patented chest strap (PCS) in patients undergoing endoscopic transaxillary thyroidectomy. Patients older than 18&#xa0;years who underwent the procedure with or without the chest strap were enrolled. The primary endpoints included postoperative drainage outcomes and total usage of the PCS, which served as measures of effectiveness. Secondary endpoints focused on strap-related complaints, assessed in comparison with traditional bandages (TB), to evaluate safety. A total of 108 patients were included in the PCS group and 126 in the TB group. In the PCS group, the mean age was 43.5 ± 16.2&#xa0;years, and 61 patients (56.48%) were female. Compared with the TB group, the PCS group showed statistically significant differences in height (1.67 ± 0.03&#xa0;m vs. 1.73 ± 0.04&#xa0;m; <i>P</i> &lt; 0.00001), weight, and body mass index (<i>P</i> &lt; 0.0001). The mean postoperative drainage volume on the first day was 50&#xa0;mL in the PCS group and 48.5 ± 9.19&#xa0;mL in the TB group. Drainage volumes differed significantly between groups on the second day (36 ± 8.49&#xa0;mL vs. 44 ± 12.73&#xa0;mL; <i>P</i> &lt; 0.001) and the third day (35 ± 7.07&#xa0;mL vs. 25&#xa0;mL; <i>P</i> &lt; 0.001). The total postoperative drainage volume was lower in the PCS group than in the TB group (111.92 ± 13.44&#xa0;mL vs. 122.5 ± 24.75&#xa0;mL). Complications were more frequent in the TB group. Skin allergy occurred in 40 patients (31.75%) in the TB group compared with 9 patients (8.33%) in the PCS group. The patent chest-strap has the postoperative benefits for patients with endoscopic transanxillary thyroidectomy, and suffered fewer ratio of complications. This phase real-world study performed a positive feedback for a self-developed clinical patent transformation achievement in China.</p><p><i>Registration</i>: Chinese Clinical Trial Registry (<a href="https://www.medicalresearch.org.cn/">https://www.medicalresearch.org.cn/</a>) ChiCTR2500107867 (Registered data: 15 August, 2025)</p>

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Utility and safety of a self-developed patent chest strap in endoscopic transaxillary thyroid surgery: a prospective comparative effectiveness study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月27日

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  • Jie Shang,
  • Yi’ning Wang,
  • Xiwei Jiang,
  • Jinqing Zhang,
  • Xiaoyan Zou,
  • Ying Xu

摘要

A novel patent chest-strap was developed for use in endoscopic transaxillary thyroid surgery. We conducted a phase prospective study in China to evaluate its utility and safety. This phase 1 study evaluates the utility, safety, and effectiveness of a novel patent chest-strap in a real-world clinical patient population. This single-center, open-label, prospective, randomized study was conducted from July 1, 2025, to March 31, 2026, to evaluate the long-term safety and efficacy of a patented chest strap (PCS) in patients undergoing endoscopic transaxillary thyroidectomy. Patients older than 18 years who underwent the procedure with or without the chest strap were enrolled. The primary endpoints included postoperative drainage outcomes and total usage of the PCS, which served as measures of effectiveness. Secondary endpoints focused on strap-related complaints, assessed in comparison with traditional bandages (TB), to evaluate safety. A total of 108 patients were included in the PCS group and 126 in the TB group. In the PCS group, the mean age was 43.5 ± 16.2 years, and 61 patients (56.48%) were female. Compared with the TB group, the PCS group showed statistically significant differences in height (1.67 ± 0.03 m vs. 1.73 ± 0.04 m; P < 0.00001), weight, and body mass index (P < 0.0001). The mean postoperative drainage volume on the first day was 50 mL in the PCS group and 48.5 ± 9.19 mL in the TB group. Drainage volumes differed significantly between groups on the second day (36 ± 8.49 mL vs. 44 ± 12.73 mL; P < 0.001) and the third day (35 ± 7.07 mL vs. 25 mL; P < 0.001). The total postoperative drainage volume was lower in the PCS group than in the TB group (111.92 ± 13.44 mL vs. 122.5 ± 24.75 mL). Complications were more frequent in the TB group. Skin allergy occurred in 40 patients (31.75%) in the TB group compared with 9 patients (8.33%) in the PCS group. The patent chest-strap has the postoperative benefits for patients with endoscopic transanxillary thyroidectomy, and suffered fewer ratio of complications. This phase real-world study performed a positive feedback for a self-developed clinical patent transformation achievement in China.

Registration: Chinese Clinical Trial Registry (https://www.medicalresearch.org.cn/) ChiCTR2500107867 (Registered data: 15 August, 2025)