ZipFix Versus Conventional Sternal Closure: One-Year Follow-Up

Abstract

BACKGROUND: The present study aimed to compare postoperative complications commonly revealed after sternotomy closure by new sternal ZipFix (Synthes GmbH, Oberdorf, Switzerland) implant and conventional steel wire. METHODS: Among the initial 360 subjects, 326 patients enrolled in this randomised control trial who were candidates for cardiac surgery from April 2014 to March 2015. After the surgery, the sternal closure was randomly done with poly-ether-ether-ketone (PEEK) based sternal ZipFix (ZF) on the sternal body (n=168) or with conventional wires (CWs) (n=158). Patients were followed postoperatively as well as 1, 3, 6, and 12 months after discharge regarding postoperative complications such as pain severity, dehiscence, and infection including incisional infections (superficial or deep), and organ/space infection (mediastinitis or osteomyelitis). RESULTS: The mean age of the ZF and CW groups were 63.58+/-10.9 and 62.42+/-7.1years, respectively (p=0.262). In addition, there was no significant difference between the two groups' baseline characteristics (p>0.05). Our study showed higher mean pain severity score in the conventional closure group compared with ZipFix closure group at all study time points (p<0.001). Infection was seen in 2.76 of the overall participants with no significant difference of incisional and organ infection between the two groups throughout the study. After 1-month follow-up, five patients in the CW group had sternal dehiscence whereas no patients in ZF had dehiscence (p<0.001). CONCLUSIONS: Our trial demonstrates greater clinical advantages in terms of pain and sternal dehiscence post surgery by using sternal ZipFix compared to conventional steel wire.