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

Phase 1

Active, not recruiting

• Conditions: Prevention of Post-Cardiac Surgery Sternal Infections; MedDRA version: 20.0Level: LLTClassification code 10078408Term: Surgical site infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-002207-17-IT
• Lead Sponsor: PolyPid Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-29
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

1. Subjects scheduled to elective and/or urgent median sternotomy for cardiac surgery, who are preoperative hemodynamically stable.
2. Males and females.
3. Subjects age of 18 and older.
4. Patient with the two following comorbidities: Diabetes Mellitus AND BMI=30
OR
Patients with one of the two comorbidities Diabetes Mellitus OR BMI=30,
AND
One of the following comorbidities : Current/Previous smoking history =30 pack year
OR
Chronic Obstructive Pulmonary Disease (COPD).
5. Female of childbearing potential should have a negative serum pregnancy test prior to index procedure.
Note: All female of childbearing potential must agree to use a highly effective method of contraception ( see
Section 6.3 – CONTRACEPTIVE METHODS)
6. Subject is willing and able to provide a signed Informed Consent Form and is willing and able to comply with
study’s procedures including follow-up visits.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 560
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1040

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 D-PLEX ingredients.
5. Subjects with known allergies to more than any 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 for major organ transplantation and/or to other significant concomitant surgical procedure.
12. Subjects scheduled for mechanical assist device: left ventricular (LVAD) and/or right ventricular (RVAD), or artificial heart.
13. Subjects scheduled to be treated with preventive negative pressure devices.
14. Subjects undergone CVA/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 a highly effective contraceptive method of birth control ( see Section 6.3 – CONTRACEPTIVE METHODS).
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).
20. In the opinion of investigator, subject is not eligible to participate in the study and/or to comply with protocol requirements (e.g. due to a cognitive, medical condition or residency distanced from site that may jeopardize FU visits attendance etc.).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified