1. Prevention of sternal dehiscence with the sternum external fixation (Stern-E-Fix) corset--randomized trial in 750 patients.
- Author
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Tewarie LS, Menon AK, Hatam N, Amerini A, Moza AK, Autschbach R, and Goetzenich A
- Subjects
- Aged, Cardiac Surgical Procedures adverse effects, Cardiac Surgical Procedures statistics & numerical data, External Fixators, Humans, Length of Stay, Male, Mediastinitis epidemiology, Mediastinitis prevention & control, Middle Aged, Postoperative Complications epidemiology, Postoperative Complications prevention & control, Prospective Studies, Risk Factors, Surgical Wound Dehiscence epidemiology, Wound Closure Techniques statistics & numerical data, Cardiac Surgical Procedures methods, Sternum surgery, Surgical Wound Dehiscence prevention & control, Wound Closure Techniques instrumentation
- Abstract
Background: 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., Methods: 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., Results: 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)., Conclusions: 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.
- Published
- 2012
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