Prevention of Sternal Wound Complications after Sternotomy
Results of a Large Prospective Randomized Multicentre Trial
Prevention of Sternal Wound Complications after Sternotomy: Results of a Large Prospective Randomized Multicentre Trial
The study was conducted by Michael Gorlitzer, Florian Wagner, Steffen Pfeiffer, Sandra Folkmann, Johann Meinhart, Theodor Fischlein, Hermann Reichenspurner, and Martin Grabenwoeger. it was a cooperation of the Heat Centers of Vienna, Nuernberg and Heart Center Hamburg Eppendorf.
The objective of the study was to analyse the efficacy of a vest called "Posthorax support vest®" in preventing sternal wound infection after cardiac surgery and to identify risk factors associated with these complications.
Methods The study was conducted from September 2007 to March 2010 and involved 2539 patients who underwent cardiac surgery via median sternotomy. The patients were randomized into two groups: one group received the Posthorax® vest and the other group did not. The patients in the vest group were instructed to wear the vest for 24 hours a day for at least 6 weeks after the surgery. The follow-up period was 90 days. Patients who did not comply with the vest-wearing instructions within 72 hours after the surgery were considered study dropouts. The statistical analysis was based on an intention-to-treat (ITT) analysis, and further evaluations included all subgroups of patients.
Results
Data from 2539 patients were available for analysis. The patients had an average age of 67 years, with 45% of them being female. Of these patients, 1351 were randomized to receive the vest and 1188 did not receive the vest. There were no significant differences between the two groups in terms of age, gender, diabetes, body mass index, chronic obstructive pulmonary disease (COPD), renal failure, the logistic EuroSCORE, and the indication for surgery. The frequency of deep wound complications (mediastinitis and sternal dehiscence) was significantly lower in the vest group (1.04%) compared to the non-vest group (2.27%) (P < 0.01). However, there were no significant differences between the groups in terms of superficial wound complications.
Further analysis of the vest group revealed that only 933 patients (Group A) wore the vest according to the protocol, while 202 patients (Group BR) refused to wear the vest (non-compliance), and 216 patients (Group BN) did not use the vest for other reasons.
All cases of deep wound complications occurred in Groups BR and BN, even though these groups had the same preoperative risk profile as Group A. Group BN exhibited a prolonged intubation time, longer stay in the intensive care unit, greater use of intra-aortic balloon pump, higher frequency of COPD, and a larger percentage of patients who required prolonged surgery.
Conclusions
The study concluded that consistent use of the Posthorax® vest prevented deep sternal wound complications. The anticipated risk factors for wound complications did not prove to be relevant, while intra- and postoperative complications were found to be significant factors.
"Please note that the information provided here is based on the abstract of the study. For more detailed information and a better understanding of the study, it is recommended to refer to the full text of the article."
