Topical Prophylaxis after Cardiac Device Implantation, a Prospective, Randomized Study

摘要

Background: Combined systemic and topical antibiotic prophylaxes are used in cardiac electronic implantable device (CEID) procedures, but very few studies have assessed prophylactic use of topical antibiotics after CEID implantation. Objective: To evaluate the efficacy of topical antibiotic prophylaxis in the prevention of surgical site infection after CEID implantation procedures. Methods: This was a prospective randomized, placebo-controlled, single center, single operator study. All patients (n=1008) received standard systemic antibiotic prophylaxis. After the procedure, patients were randomized into four groups and received various topical prophylaxes. All patients were followed for at least 12 months. Surgical site inflammation and infection were graded based on degree of inflammation, discharge, wound cultures, and blood cultures. Result: Fifty-eight patients developed surgical site inflammation and infection. Fourteen patients had culture-positive wound infections. Thirteen had superficial wound infections with staphylococcus species. Only one had pocket infection with Pseudomonas bacteremia. The surgical site infection rates were higher in those with procedure time over 110 minutes, associated with 2.3 times more likelihood of infection (p = 0.01). Patients with an associated malignancy were associated with 3.6 times more likelihood of infection (p <0.01). Conclusions: Careful skin preparation prior to incision is important whereas the use of topical antibiotics after closure has not shown significant benefit. Patients with malignancy and longer procedural times are more likely to develop infection. There is a trend for less CEID infection with the cephalic approach. Systemic antibiotics with staphylococcal coverage are needed for prophylaxis as most of the wound culture positive infections are caused by staphylococcus species.