Tewarie Lachmandath S, Menon Ares K, Hatam Nima, Amerini Andrea, Moza Ajay K, Autschbach Rüdiger, Goetzenich Andreas
Department of Cardiothoracic and Vascular Surgery, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074 Aachen, Germany.
J Cardiothorac Surg. 2012 Sep 9;7:85. doi: 10.1186/1749-8090-7-85.
The main objective of this study will be to determine the effects of a new advanced sternum external fixation (Stern-E-Fix) corset on prevention of sternal instability and mediastinitis in high-risk patients.
This prospective, randomized study (January 2009 - June 2011) comprised 750 male patients undergoing standard median sternotomy for cardiac procedures (78% CABG). Patients were divided in two randomized groups (A, n = 380: received a Stern-E-Fix corset postoperatively for 6 weeks and B, n = 370: control group received a standard elastic thorax bandage). In both groups, risk factors for sternal dehiscence and preoperative preparations were similar.
Wound infections occurred in n = 13 (3.42%) pts. in group A vs. n = 35 (9.46%) in group B. In group A, only 1 patient presented with sternal dehiscence vs. 22 pts. in group B. In all 22 patients, sternal rewiring followed by antibiotic therapy was needed. Mediastinitis related mortality was none in A versus two in B. Treatment failure in group B was more than five times higher than in A (p = 0.01); the mean length of stay in hospital was 12.5 ± 7.4 days (A) versus 18 ± 15.1 days (B) (p=0.002). Re-operation for sternal infection was 4 times higher in group B. Mean ventilation time was relatively longer in B (2.5 vs. 1.28 days) (p = 0.01). The mean follow-up period was 8 weeks (range 6 - 12 weeks).
We demonstrated that using an external supportive sternal corset (Stern-E-Fix) yields a significantly better and effective prevention against development of sternal dehiscence and secondary sternal infection in high-risk poststernotomy patients.
本研究的主要目的是确定一种新型先进的胸骨外固定（Stern-E-Fix）束腹带对高危患者预防胸骨不稳定和纵隔炎的效果。
这项前瞻性随机研究（2009年1月至2011年6月）纳入了750例行心脏手术标准正中胸骨切开术的男性患者（78%为冠状动脉旁路移植术）。患者被随机分为两组（A组，n = 380：术后使用Stern-E-Fix束腹带6周；B组，n = 370：对照组使用标准弹性胸带）。两组中，胸骨裂开的危险因素和术前准备情况相似。
A组有n = 13例（3.42%）患者发生伤口感染，而B组有n = 35例（9.46%）。A组仅有1例患者出现胸骨裂开，而B组有22例。在所有22例患者中，均需要进行胸骨重新缝合并给予抗生素治疗。A组无纵隔炎相关死亡病例，B组有2例。B组的治疗失败率比A组高5倍以上（p = 0.01）；平均住院时间为12.5±7.4天（A组） vs. 18±15.1天（B组）（p = 0.002）。B组因胸骨感染再次手术的发生率是A组的4倍。B组的平均通气时间相对较长（2.5天 vs. 1.28天）（p = 0.01）。平均随访期为8周（范围6 - 12周）。
我们证明，使用外部支持性胸骨束腹带（Stern-E-Fix）能显著更好且有效地预防高危胸骨切开术后患者发生胸骨裂开和继发性胸骨感染。
