Abstract 13882: Final Results of the World Largest Prospective Randomized Multicenter Trial Regarding Prevention of Sternal Wound Complications After Open Heart Surgery
Objective: A prospective randomized mulitcenter trial was performed for analyzing efficacy of a specifically designed vest (Posthorax support vest) to prevent sternal wound infections after cardiac surgery and identify risk factors.
Methods:From 07/2008 until 03/2010 n=2632 patients undergoing cardiac surgery via median sternotomy were randomized to receive a Posthorax® vest or not. Patients were instructed to wear the vest postoperatively 24hrs/day for at least 6 weeks, follow-up was 90days. Protocol drop out occurred if no vest was applied within 72hrs. postoperatively. Main statistics are based on an intention-to-treat(ITT) analysis. Further analysis involved all subgroups including drop out patients.
Findings:Complete data were available for n=2539 patients (age 67±11years, 45% female). N=1351 were randomized to a vest versus n=1188 to no vest. There was no significant difference between groups regarding age, gender, diabetes, BMI, COPD, renal failure, logistic EuroScore, surgery indication and bilateral mammary artery. Incidence of deep wound complications (dWC: mediastinitis, sternal dehiscence) was statistically significantly lower in vest n=14(1,04%) vs. n=27(2,27%) in no-vest group (ITT, p<0,01), superficial complications(sWC) shows no difference between both groups. Subanalysis of vest patients revealed only n=933(Gr.A) wore the vest according to protocol, while n=202(Gr.BR) refused wearing the vest(non-compliance), n=216(Gr.BN) dropped out of study (failed vest application <72hours). All observed dWC occurred in groups BR(n=7) and BN(n=7) despite identical preoperative risk profile with Gr.A. Postoperatively Gr.BN revealed statistically elevated intubation time, length of ICU stay, use of IABP, incidence of COPD and percentage of patients with prolonged surgery.
Conclusion:Consequent application of the Posthorax® vest eliminated deep sternal wound complications. Expected risk factors for wound complications did not prove to be relevant whereas complicated intra- and postoperative course seem of outstanding importance.
- © 2011 by American Heart Association, Inc.