Prevention of sternal dehiscence with the Sternum External Fixation (Stern-E-Fix) corset – a randomized trial in 750 patients

• Main Authors: Tewarie Lachmandath S, Menon Ares K, Hatam Nima, Amerini Andrea, Moza Ajay K, Autschbach Rüdiger, Goetzenich Andreas
• Format: Article
• Language: English
• Published: BMC 2012-09-01
• Series: Journal of Cardiothoracic Surgery
• Subjects: Cardiac surgery; Sternal dehiscence; Mediastinitis; Sternum external fixation corset (Stern-E-Fix)
• Online Access: http://www.cardiothoracicsurgery.org/content/7/1/85

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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).</p> <p>Conclusions</p> <p>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.</p>