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Abstract：
BACKGROUND: Coronary artery bypass graft surgery (CABG) is one of the principle therapies for coronary artery disease, as it improves survival rate and quality of life (QoL). Polypropylene suture is commonly used in vascular and cardiac surgeries for anastomosis due to its long-term tensile strength and minimal tissue trauma. This study compared the clinical equivalence of Trulene® (Healthium Medtech Limited) and Prolene® (Ethicon-Johnson & Johnson) polypropylene sutures regarding incidence of myocardial infarction, stroke, renal failure and cardiac death (MACCE) occurring up to 26 weeks\' period post-CABG surgery.
METHODS: This multicenter, prospective, two-arm, parallel-group, randomized (1:1), single-blind study (n = 89) was conducted between August 2020 and September 2021. The primary endpoint, post-surgery cumulative incidence of MACCE was evaluated. In addition, anastomotic revision, surgical site infection (SSI), operative time, length of post-operative hospital stay, repeat revascularization, intraoperative suture handling characteristics, time taken to return to work and resume normal day to day activities, subject satisfaction score and QoL, and other adverse events were also recorded.
RESULTS: A total of 80 (89.89%) males and 9 (10.11%) females participated in the study. No incidence of MACCE was recorded in any of the study participants. Non-significant difference was observed in anastomotic revision, SSI, operative time, post-operative hospital stay, revascularization, return to work and normal day-to-day activities, subject satisfaction score and QoL, and intraoperative handling parameters (except ease of passage) between the treatment groups, Trulene® and Prolene®. Compared to screening visit, proportion of subjects with \'no problems\' for each QoL dimension and the mean visual analogue scale increased with each subsequent follow-up visit.
CONCLUSIONS: Trulene® polypropylene suture is clinically equivalent to Prolene® polypropylene suture and is safe and effective for anastomosis construction in CABG surgery during a routine clinical procedure. Trial registration CTRI Registration No.: CTRI/2020/05/025157 (Registered on: 13/05/2020).
METHODS: This multicenter, prospective, two-arm, parallel-group, randomized (1:1), single-blind study (n = 89) was conducted between August 2020 and September 2021. The primary endpoint, post-surgery cumulative incidence of MACCE was evaluated. In addition, anastomotic revision, surgical site infection (SSI), operative time, length of post-operative hospital stay, repeat revascularization, intraoperative suture handling characteristics, time taken to return to work and resume normal day to day activities, subject satisfaction score and QoL, and other adverse events were also recorded.
RESULTS: A total of 80 (89.89%) males and 9 (10.11%) females participated in the study. No incidence of MACCE was recorded in any of the study participants. Non-significant difference was observed in anastomotic revision, SSI, operative time, post-operative hospital stay, revascularization, return to work and normal day-to-day activities, subject satisfaction score and QoL, and intraoperative handling parameters (except ease of passage) between the treatment groups, Trulene® and Prolene®. Compared to screening visit, proportion of subjects with \'no problems\' for each QoL dimension and the mean visual analogue scale increased with each subsequent follow-up visit.
CONCLUSIONS: Trulene® polypropylene suture is clinically equivalent to Prolene® polypropylene suture and is safe and effective for anastomosis construction in CABG surgery during a routine clinical procedure. Trial registration CTRI Registration No.: CTRI/2020/05/025157 (Registered on: 13/05/2020).
摘要：
背景：冠状动脉旁路移植术（CABG）是冠状动脉疾病的主要治疗方法之一，因为它提高了生存率和生活质量（QoL）。聚丙烯缝合线由于其长期拉伸强度和最小的组织创伤而通常用于血管和心脏手术中进行吻合。本研究比较了Trulene®（HealthiumMedtechLimited）和Prolene®（Ethicon-Johnson&Johnson）聚丙烯缝合线在心肌梗死发生率方面的临床等效性，中风,CABG手术后长达26周的肾功能衰竭和心脏死亡（MACCE）。
方法：这个多中心，prospective,双臂，平行组，随机化（1：1），单盲研究（n=89）于2020年8月至2021年9月进行。主端点，评估了术后MACCE的累积发生率.此外,吻合口翻修术,手术部位感染（SSI），手术时间,术后住院时间,重复血运重建,术中缝合处理特点，恢复工作和恢复正常的日常活动所需的时间，受试者满意度得分和QoL，并记录了其他不良事件.
结果：共有80名（89.89%）男性和9名（10.11%）女性参与了这项研究。在任何研究参与者中都没有记录到MACCE的发生率。在吻合口翻修中观察到无显着差异，SSI,手术时间,术后住院时间,血运重建,恢复工作和正常的日常活动，受试者满意度得分和QoL，治疗组之间的术中处理参数（除了通道的难易程度），Trulene®和Prolene®。与筛查访问相比，每个QoL维度和平均视觉模拟量表均无问题的受试者比例随着每次后续随访而增加。
结论：Trulene®聚丙烯缝合线在临床上与Prolene®聚丙烯缝合线相当，在常规临床手术中用于CABG手术的吻合结构是安全有效的。试用注册CTRI注册号：CTRI/2020/05/025157（注册时间：2020年5月13日）。
方法：这个多中心，prospective,双臂，平行组，随机化（1：1），单盲研究（n=89）于2020年8月至2021年9月进行。主端点，评估了术后MACCE的累积发生率.此外,吻合口翻修术,手术部位感染（SSI），手术时间,术后住院时间,重复血运重建,术中缝合处理特点，恢复工作和恢复正常的日常活动所需的时间，受试者满意度得分和QoL，并记录了其他不良事件.
结果：共有80名（89.89%）男性和9名（10.11%）女性参与了这项研究。在任何研究参与者中都没有记录到MACCE的发生率。在吻合口翻修中观察到无显着差异，SSI,手术时间,术后住院时间,血运重建,恢复工作和正常的日常活动，受试者满意度得分和QoL，治疗组之间的术中处理参数（除了通道的难易程度），Trulene®和Prolene®。与筛查访问相比，每个QoL维度和平均视觉模拟量表均无问题的受试者比例随着每次后续随访而增加。
结论：Trulene®聚丙烯缝合线在临床上与Prolene®聚丙烯缝合线相当，在常规临床手术中用于CABG手术的吻合结构是安全有效的。试用注册CTRI注册号：CTRI/2020/05/025157（注册时间：2020年5月13日）。
