Prevention of Post-Cardiac Surgery Sternal Infections MedDRA version: 20.0 Level: LLT Classification code 10078408 Term: Surgical site infection System Organ Class: 100000004862 MedDRA version: 20.0 Level: LLT Classification code 10078408 Term: Surgical site infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: Gentamicina
Product Code: [Gentamicina]
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: GEMCITABINA
Current Sponsor code: Gentamicina
Concentration unit: mg/ml
Sponsors
PolyPid Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess D-PLEX efficacy in preventing sternal infections over a period of 90 days (3 months) post cardiac surgery with median sternotomy, in patients with high risk for infection compared to the control arm. - To assess D-PLEX safety;Secondary Objective: NA;Primary end point(s): - Infection rate as measured by the proportion of subjects with a sternal wound infection event within 90 days (3 months) post sternotomy for cardiac surgery. - Sternal infection is composed of Deep Sternal Wound Infection (DSWI) and Superficial Sternal Wound Infection (SSWI). - Mortality from any reason within 90 days (3 months) post sternotomy, will be analyzed as treatment failure.;Timepoint(s) of evaluation of this end point: 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Efficacy Endpoints: • Average number of Hospitalization days post sternotomy, due to sternal infection. • Average ASEPSIS assessment score during 90 days (3 month) post sternotomy. • Number of surgical re-intervention due to sternal surgical site infections (including OR and non-OR/bed-side, procedures) ‘Other Secondary’ Endpoints (requested by regulators): • Incidence of Superficial Sternal Wound Infections (SSWI) during 90 days (3 months) post sternotomy. • Incidence of Deep Sternal Wound Infection (DSWI) during 90 days (3 months) post sternotomy. • Mortality rate associated with Sternal Wound Infection (SWI) within 90 days (3 month) post sternotomy. • Determination of susceptibility to Doxycycline of any organism recovered from a Sternal Surgical Site Infection. Additional Secondary Efficacy Endpoints • Overall number of hospitalization days, for any reason. • Number of readmissions due to Sternal Surgical Site infection. • Average number of Antibiotic Treatment (overall IV and other administration modes, e.g. oral) days due to Sternal Surgical Site infection (SSWI & DSWI). • Average number of Antibiotic Treatment (IV) days due to Sternal Surgical Site infection (SSWI and DSWI). • Time to sternal wound infection (Post Operating Day) post sternotomy. • Average number of analgesic treatment days. • Pain VAS Score assessment. Safety Endpoints The following safety parameters will be evaluated during the trial period (6 months): • Adverse events, physical examinations & vital signs. • Sternum stability, as indication for sternal bone union, will be clinically evaluated by an investigator that was not involved in the surgery, and is blinded to the treatment arm. In case of suspected instability at end of study visit (6 months after surgery), a chest CT (non-contrast) will be performed. • Surgical wound healing will be assessed by physical examination by an investigator, that was not involved in the surgery, and is blinded to the | — |
Countries
Bulgaria, Hungary, Israel, Italy, Poland, Romania, United States
Contacts
Public ContactClinical Operation Manager
PolyPid Ltd.
Outcome results
None listed