{Reference Type}: Journal Article
{Title}: Local prolonged release of antibiotic for prevention of sternal wound infections postcardiac surgery-A novel technology.
{Author}: Kachel E;Moshkovitz Y;Sternik L;Sahar G;Grosman-Rimon L;Belotserkovsky O;Reichart M;Stark Y;Emanuel N;
{Journal}: J Card Surg
{Volume}: 35
{Issue}: 10
{Year}: Oct 2020
{Factor}: 1.778
{DOI}: 10.1111/jocs.14890
{Abstract}: <B>BACKGROUND: </B>Sternal wound infection (SWI) is a devastating postcardiac surgical complication. D-PLEX100 (D-PLEX) is a localized prolonged release compound applied as a prophylactic at the completion of surgery to prevent SWI. The D-PLEX technology platform is built as a matrix of alternating layers of polymers and lipids, entrapping an antibiotic (doxycycline). The objective of this study was to assess the safety profile and pharmacokinetics of D-PLEX in reducing SWI rates postcardiac surgery.<BR><B>METHODS: </B>Eighty-one patients were enrolled in a prospective single-blind randomized controlled multicenter study. Sixty patients were treated with both D-PLEX and standard of care (SOC) and 21 with SOC alone. Both groups were followed 6 months for safety endpoints. SWI was assessed at 90 days.<BR><B>RESULTS: </B>No SWI-related serious adverse events (SAEs) occurred in either group. The mean plasma Cmax in patients treated with D-PLEX was about 10 times lower than the value detected following the oral administration of doxycycline hyclate with an equivalent overall dose, and followed by a very low plasma concentration over the next 30 days. There were no sternal infections in the D-PLEX group (0/60) while there was one patient with a sternal infection in the control group (1/21, 4.8%).<BR><B>CONCLUSIONS: </B>D-PLEX was found to be safe for use in cardiac surgery patients. By providing localized prophylactic prolonged release of broad-spectrum antibiotics, D-PLEX has the potential to prevent SWI postcardiac surgery and long-term postoperative hospitalization, reducing high-treatment costs, morbidity, and mortality.