Noyez L, Verkroost M W, van Asten W N, Kaan G L, Lacquet L K
Department of Thoracic and Cardiac Surgery, University Hospital Nijmegen St Radboud, The Netherlands.
Cardiovasc Surg. 1993 Dec;1(6):643-5.
A clinical trial was performed to evaluate sternal closure with the controlled tension osteosynthesis system and closure with twisted stainless steel wires. Some 451 consecutive patients who underwent isolated coronary bypass surgery between January 1991 and December 1991 were subdivided into three groups. Patients in group A (94 patients) and group B (98 patients) were all operated on by one surgeon, to reduce variability before, at the time of and after surgery, which might influence sternal wound healing. To exclude a possible preference of the surgeon in the study, group C was formed, consisting of 259 patients operated on by other hospital surgeons. In groups A and C, sternal closure was performed with the controlled tension osteosynthesis system. In group B, sternal closure was performed with (six) twisted stainless steel wires. Among groups A, B and C, no statistical significant difference could be found between the rate and the type of sternal wound complications. Despite this finding, there were significantly more reoperations, a longer cross-clamp time and more extensive use of the internal mammary artery as a graft in group B. Despite the non-randomization of the study, and the small patient numbers being a limitation, the use of the controlled tension osteosynthesis system in adults did not result in a decrease of early sternal wound complications.
进行了一项临床试验，以评估使用可控张力骨合成系统闭合胸骨与使用不锈钢丝扭转闭合胸骨的效果。1991年1月至1991年12月期间连续接受单纯冠状动脉搭桥手术的约451例患者被分为三组。A组（94例患者）和B组（98例患者）均由同一位外科医生进行手术，以减少手术前、手术时和手术后可能影响胸骨伤口愈合的变异性。为了排除外科医生在研究中的可能偏好，设立了C组，由其他医院外科医生手术的259例患者组成。A组和C组采用可控张力骨合成系统闭合胸骨。B组采用（六根）不锈钢丝扭转闭合胸骨。在A、B、C三组之间，胸骨伤口并发症的发生率和类型没有统计学上的显著差异。尽管有这一发现，但B组的再次手术明显更多，体外循环时间更长，乳内动脉作为移植物的使用也更广泛。尽管该研究未进行随机分组，且患者数量较少是一个限制因素，但在成人中使用可控张力骨合成系统并未导致早期胸骨伤口并发症减少。
