Skin sealant InteguSeal® has no impact on prevention of postoperative mediastinitis after cardiac surgery

Objective: Surgical Site Infections (SSI) after median sternotomy represent a serious complication and a high potential risk for adverse clinical outcome after cardiac surgery. This single-center investigation uses two prospective registries to evaluate the prophylactic effect of a cyanoacrylate-based anti-microbial skin sealant (InteguSeal®) on the incidence of postoperative mediastinitis or any other form of chest skin incision SSI after elective cardiac surgery.

Methods: Between October 2010 and April 2011 a total of 1002 patients underwent elective cardiac surgical procedures with median sternotomy in the Dresden Heart Center. Registry 1: 498 patients (376 male, 122 female) with inclusion of administration of InteguSeal® into standard preoperative disinfection procedures prior to chest skin incision according to manufacturer instructions and hospital-specific internal guidelines. Registry 2: 504 patients (358 male, 146 female) with standard preoperative preparation prior to chest skin incision. Freedom of mediastinitis within 30 postoperative days in registry 1 versus registry 2 was the primary endpoint. Secondary endpoints were duration of hospitalization, duration of ICU treatment, survival and freedom of any other form of SSI within 30 postoperative days.

Results: Incidence of postoperative mediastinitis was 2.8% in registry 1 vs. 3.6% in registry 2, showing no significant differences between registries (p=0.511). Incidence of any form of chest skin incision SSI was 12.5% in registry 1 vs. 13.1% in registry 2, again without significant differences between registries (p=0.550). Baseline patient characteristics, complexity of surgical procedures performed, length of hospitalization and in-hospital mortality were similar in both registries. Known SSI risk factors were equally accentuated in both registries and their detrimental influence on postoperative SSI rate was not mitigated by InteguSeal® application.

Conclusion: Use of InteguSeal® has no influence on the incidence rate of postoperative SSI and mediastinitis in elective cardiac surgery procedures with median sternotomy. Furthermore no positive effect was observed on in-hospital death and duration of ICU or hospital treatment.