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

Abstract

BackgroundThe 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.MethodsThis 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.ResultsWound 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).ConclusionsWe 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.

Prevention of Sternal Wound Infections in Women Using an External Sternum Fixation Corset

“…Some of them tend to be useful in preventing instability and infection of the sternum and should reduce postoperative pain, thereby improving the clinical course and the postoperative quality of life. [5][6][7] Using the external supportive sternal Stern-E-Fix (Fendel & Keuchen GmbH, Aachen, Germany) corset is shown to yield a significantly better and effective prevention against development of sternal dehiscence and secondary sternal wound infection (SWI) in high-risk poststernotomy male patients. 6) The aim of this study is to assess the prevention of SWI, DSWI, and mediastinitis after median sternotomy in high-risk female patients using the Stern-E-Fix corset.…”

Sternal closure methods in high-risk patients: Should they be specific to the patient?

“…The postoperative mechanical ventilation requirement of the patients was 8.2±2.1 (3.9-12.1) hours for the first group and 9.1±2.3 (4.3-11.4) hours for the second group. There was no significant difference between the systems, kryptonite bone glues, plastics, and titanium cables [11] . Cardiovascular surgeons have to fight for different reasons in almost every patient have risk of dehiscence.…”

Effects of Polyglyconate (Maxon) Suture Reinforced Sternum Closure Technique on Aseptic Sternal Dehiscence in High Risk Patients

“…But this technique is somehow troublesome and if care is not taken unwanted devastating results can be occur in osteoporotic patients (7) . Thermoreactive nitinol clips, rigid plate fi xation, sternum external fi xation corset, kryptonite bone adhesive, sternoband studies shows their effectiveness to prevent dehiscence, but it's obvious that these materials will increase hospital costs in some degree (8)(9)(10)(11)(12) .…”