title: Prevention of sternal dehiscence with the sternum external fixation (Stern-E-Fix) corset--randomized trial in 750 patients.
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.
authors.affiliation: Department of Cardiothoracic and Vascular Surgery, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074 Aachen, Germany. ltewarie@ukaachen.de
authors.forename: Lachmandath S
authors.initials: LS
authors.lastname: Tewarie
authors.forename: Ares K
authors.initials: AK
authors.lastname: Menon
authors.forename: Nima
authors.initials: N
authors.lastname: Hatam
authors.forename: Andrea
authors.initials: A
authors.lastname: Amerini
authors.forename: Ajay K
authors.initials: AK
authors.lastname: Moza
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Autschbach
authors.forename: Andreas
authors.initials: A
authors.lastname: Goetzenich
mesh_terms: D000368:Aged; D006348:Cardiac Surgical Procedures / Q000009:adverse effects / Q000379:methods* / Q000706:statistics & numerical data; D016267:External Fixators; D006801:Humans; D007902:Length of Stay; D008297:Male; D008480:Mediastinitis / Q000453:epidemiology / Q000517:prevention & control; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control; D011446:Prospective Studies; D012307:Risk Factors; D013249:Sternum / Q000601:surgery*; D013529:Surgical Wound Dehiscence / Q000453:epidemiology / Q000517:prevention & control*; D058106:Wound Closure Techniques / Q000295:instrumentation* / Q000706:statistics & numerical data