The researchers found no significant difference in sternal wound infections in patients randomized to the gentamicin-collagen sponge group (63/753; 8.4 percent) compared with patients in the control group (65/749; 8.7 percent). No significant differences were observed between the sponge group and the control group, respectively, in superficial sternal wound infections (6.5 percent vs. 6.1 percent), deep sternal wound infection (1.9 percent vs. 2.5 percent) or rehospitalization for sternal wound infection (3.1 percent vs. 3.2 percent).

"These findings directly contradict the data previously available on the efficacy of this technology in wound infection prevention," the authors write.

Regarding why their findings are in such contrast to those of the Swedish study, the researchers add that there were important differences between the studies, including several important quality-control measures that were not incorporated in the previous study, as well as ethnic and regional differences, that may have produced differing results."In conclusion, despite approval of the gentamicin-collagen sponge in 54 countries outside of the United States and positive results from a large Swedish trial, our large multicenter U.S. trial did not find the gentamicin-collagen sponge to be effective at preventing sternal wound infection in the setting of cardiac surgery."

Source : JAMA