The gentamicin-collagen sponge which is a surgically implantable topical antibiotic is presently accepted in 54 countries and around 2 million sponges have been used to treat more than 1 million patients outside the United States. Experts share that insertion of the gentamicin-collagen sponge during surgical closure does not lower the rate of sternal wound infection.
Previous analysis conducted in Sweden revealed that the sponge lowered surgical site infection among around 50 percent cardiac patients. Scientists involved in the study conducted a three phase randomized controlled trial to evaluate previous data and support regulatory approval in the United States.
“Despite the use of prophylactic systemic antibiotics, postoperative sternal wound infection continues to be a serious problem after cardiac surgical procedures, especially in the increasing population of patients with diabetes and/or obesity. Sternal wound infection is associated with significant suffering, additional expense, lengthened hospital stay, and increased mortality,” authors remarked.
The trial included 1,502 cardiac patients who were at an augmented risk for sternal wound infection. These participants were enlisted from 48 different sites in the U.S. and the study was carried from December 2007 to March 2009. The patients were classified into two groups one included those who administered two gentamicin-collagen sponge insertion between the sternal halves and the other who did not receive any intervention during surgical closure. Experts revealed that all patients received adequate standardized care including prophylactic systemic antibiotics.
Authors shared, “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.”
The scientists did not identify any essential difference in sternal wound infections among patients randomized to the gentamicin-collagen sponge group as compared to those who were a part of the control group. There was mainly no vital difference in superficial sternal wound infections, deep sternal wound infection or rehospitalization for sternal wound infection.
“These findings directly contradict the data previously available on the efficacy of this technology in wound infection prevention,” authors added.
Experts highlighted that there were major differences among the present analysis and the Swedish analysis. These differences were mainly because of variation in quality-control measures, ethnic and regional attributes of the participants.
These findings were published in the August 18 issue of JAMA.