Local prolonged release of antibiotic for prevention of sternal wound infections postcardiac surgery—A novel technology

Erez Kachel, Yaron Moshkovitz, Leonid Sternik, Gideon Sahar, Liza Grosman-Rimon, Olga Belotserkovsky, Malka Reichart, Yafit Stark, Noam Emanuel

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Introduction: 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. Method: 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. Results: 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%). Conclusion: 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.

Original languageEnglish
Pages (from-to)2695-2703
Number of pages9
JournalJournal of Cardiac Surgery
Volume35
Issue number10
DOIs
StatePublished - 1 Oct 2020
Externally publishedYes

Keywords

  • D-PLEX technology
  • antibiotics
  • cardiac surgery
  • sternal wound infections

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