Efficacy of Sternum Guard vs. bone wax in post-cardiac surgery patients: a randomized controlled trial.

Background: Median sternotomy offers the main access during cardiac surgery. However, a surgical site infection (SSI) of the sternum is a distressing complication following this procedure. The incidence of postoperative superficial and deep SSI in cardiac surgery varies from 1.3% to 12.8%. Bone wax, a nonabsorbable substance applied as a mechanical barrier following a median sternotomy, can increase the risk of postoperative sternal dehiscence. Sternum Guard (Vygon, Ecouen, France), a sternal protection device used to cover the sternum after a median sternotomy, offers mechanical protection to prevent lesions on the sternum. The aim of this study was to compare the effectiveness of Sternum Guard (Vygon) and bone wax in reducing SSI and facilitating hemostasis in post-cardiac surgery patients.

Methods: This single-blinded, single center randomized controlled trial comprised 414 adult patients who underwent cardiac surgery. The postoperative outcomes assessed were SSI and the quantity of blood lost from the sternal edges in the Sternum Guard (Vygon; treatment) and bone wax (control) groups.

Results: The superficial SSI prevalence in the Sternum Guard group was lower than that in the bone wax group (2.9% vs. 8.2%, respectively; P=0.018). The incidence of deep SSI was also lower in the Sternum Guard group (1%) compared to the control group (2.9%) although this was not statistically significant (P=0.284). In terms of intraoperative sternal bleeding, Sternum Guard (Vygon) absorbed more than the sterile drapes used in the control group (84.97±115.99 vs. 81.18±14.62, respectively; P=0.012).

Conclusions: Sternum Guard (Vygon) had a significantly lower incidence of postoperative infection and bleeding from the sternum compared to bone wax.