Prevention of sternal dehiscence and infection in high-risk patients: A prospective randomised multicenter trial

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Objectives: One factor for the development of sternal wound infection (SWI) is bony instability. This study compares two surgical techniques regarding the occurrence of SWI in patients with an increased risk. Methods: 815 consecutive high-risk patients were prospectively randomised to a conventional osteosynthesis (trans/peristernal wiring; n=440) or to an osteosynthesis with additional lateral reinforcement (Robicsek; n=375). Primary end-points were the rate of sternal dehiscence (SD) as well as the occurrence of superficial (SSWI) and deep (DSWI) sternal wound infections; secondary end-points included a composite of clinical parameters. Results: Both groups were comparable concerning pre,- and intraoperative variables. The rate of SD, SSWI, and DSWI (conventional technique: 2.5%; 3.4%; 2.5%/Robicsek: 3.7%; 5.6%; 3.7%) did not differ between the groups. There were also no difference according to the secondary end-points between the two compared groups (mechanical ventilation, p=0.95; blood loss in ICU, p=0.55; transfusion of RBU, GFP, Thrombocytes, p=0.54, 0.87, 0.35; reexploration for bleeding, p=0.77; postoperative delirium, p=0.27; ICU-stay, p=0.49; hospital-stay, p=0.42; mortality related to DSWI, p=0.90). Conclusion: The methodological strength of this trial is that the influence of the surgical performance in a multicenter approach leads to an obvious consideration of the individual surgical influence. Especially if a more complex technique seems theoretically to be superior (one surgeon's results), it is not able to achieve the requirements under „real-life“ conditions. Therefore, in this setting we did not observe any benefit of a reinforced osteosynthesis according to the Robicsek technique in patients with an increased risk for sternal wound complications.

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