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.

Validation in Indonesia of two published scores for mortality prediction after cardiac surgery.

Introduction: No mortality risk prediction model has previously been validated for cardiac surgery in Indonesia. This study aimed at validating the EuroSCORE II and Age Creatinine Ejection Fraction (ACEF) score as predictors for in-hospital mortality after cardiac surgery a in tertiary center, and if necessary, to recalibrate the EuroSCORE II model to our population. Methods: This study was a single-center observational study from prospectively collected data on adult patients undergoing cardiac surgery from January 2006 to December 2011 (n = 1833). EuroSCORE II and ACEF scores were calculated for all patients to predict in-hospital mortality. Discrimination was assessed using the area under the curve (AUC) with a 95% confidence interval. Calibration was assessed with the Hosmer-Lemeshow test (HL test). Multivariable analysis was performed to recalibrate the EuroSCORE II; variables with P < 0.2 entered the final model. Results: The in-hospital mortality rate was 3.8%, which was underestimated by the EuroSCORE II (2.1%) and the ACEF score (2.4%). EuroSCORE II (AUC 0.774 (0.714-0.834)) showed good discrimination, whereas the ACEF score (AUC 0.638 [0.561-0.718]) showed poor discrimination. The differences in AUC were significant (P = 0.002). Both scores were poorly calibrated (EuroSCORE II: HL test P < 0.001, ACEF score: HL test P < 0.001) and underestimated mortality in all risk groups. After recalibration, EuroSCORE II showed good discrimination (AUC 0.776 [0.714- 0.840]) and calibration (HL test P = 0.79). Conclusions: EuroSCORE II and the ACEF score were unsuitable for risk prediction of in-hospital mortality after cardiac surgery in our center. Following recalibration, the calibration of the EuroSCORE II was greatly improved.