D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery

Exclusion Criteria

• •1. Subjects undergoing partial sternotomy.
• •2. Subjects with any preoperative active significant infection.
• •3. Subjects that received oral or IV doxycycline during the last 4 weeks prior to screening.
• •4. Subjects with sensitivity to doxycycline and/or to tetracycline family of drugs and/or other study drug ingredients.
• •5. Subjects with known allergies to more than 3 substances. (An allergy questionnaire will be filled during the screening process).
• •6. Subjects with history of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with intra-venous steroids/epinephrine or in the opinion of the investigator the patient is at high risk of developing severe allergic/hypersensitivity reactions.
• •7. Subjects with uncontrolled Asthma (GINA III-IV).
• •8. Subjects with chronic urticaria.
• •9. Immunocompromised subjects from any reason, at screening.
• •10. Subjects with renal failure requiring dialysis.
• •11. Subjects scheduled to major organ transplantation and/or to other significant concomitant surgical procedure.
• •12. Subjects scheduled for mechanical assist device.
• •13. Subjects scheduled to be treated with preventive negative pressure devices.
• •14. Subjects undergone Cerebro-Vascular Accident (CVA)/Transient Ischemic Attack (TIA) within the past 3 months prior to randomization.
• •15. Subjects that have undergone previously, any cardiac surgery through sternotomy.
• •16. Subjects with active or previous malignancy in the chest area.
• •17. Any subject with active malignancy or with malignancy that has not been in complete remission for at least 5 years. Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma of the skin and basal cell carcinoma of the skin, are eligible.
• •18. Pregnant or breast-feeding women or women of childbearing age not protected by an effective contraceptive method of birth control (such as double barrier, oral or parenteral hormonal, intrauterine device and spermicide).
• •19. Subjects enrolled in any intervention study with an investigational medicinal product and/or received any investigational medicinal product within 30 days or 5½ half-lives of the product prior to enrollment (whichever is longer).