학술논문

Local prolonged release of antibiotic for prevention of sternal wound infections postcardiac surgery-A novel technology.
Document Type
Journal Article
Source
Journal of Cardiac Surgery. Oct2020, Vol. 35 Issue 10, p2695-2703. 9p. 1 Color Photograph, 1 Diagram, 5 Charts, 1 Graph.
Subject
*Wound infections
*Infection control
*Surgical complications
*Cardiac surgery
*Surgery
*Controlled release drugs
*Research
*Sternum
*Thoracic surgery
*Research methodology
*Evaluation research
*Medical cooperation
*Antibiotic prophylaxis
*Comparative studies
*Randomized controlled trials
*Surgical site infections
*Blind experiment
*Research funding
*Statistical sampling
*Antibiotics
*Longitudinal method
*Dosage forms of drugs
Language
ISSN
0886-0440
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. [ABSTRACT FROM AUTHOR]