This study is aimed to assess the anti-infective efficacy of D-PLEX over a period of 3 months post operation as well as the safety over a period of 6 months, by preventing sternal infection post cardiac surgery in patients above the age of 18, including high risk patients for infection. This study is a 2 parts study: part 1 is a single arm, part 2 is randomized controlled study.
D-PLEX is a new formulation of extended controlled release Doxycycline. Subjects who meet the eligibility criteria and provide signed informed consent, will be enrolled into the study and will be treated with D-PLEX concomitantly with standard of care. D-PLEX will be administered as a single application during a cardiac surgery (index procedure) immediately prior to sternal closure, as an adjunct to the standard care. The study will assess the efficacy and safety of the controlled release antibiotic (doxycycline) by the reduction in the number of sternal infections observed during the treatment period in any subject above the age of 18 years, including patients with high risk for infection. Additional follow up for prolonged safety assessments only, will be done as follows until 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
81
D-PLEX will be administered as a single application during the open heart surgery (index procedure) immediately prior to sternal closure, as an adjunct to the standard care.
Subject will undergo open heart surgery according to standard of care
Soroka Medical Center
Beersheba, Israel
Rambam Medical Center
Haifa, Israel
Assuta Medical Center
Tel Aviv, Israel
Sheba Medical Center
Tel Litwinsky, Israel
Poriya Medical Center
Tiberias, Israel
Decrease of Infection Rate as Measured by the Proportion of Subjects With at Least 1 Identified Sternal Infection Within 90 Days Post-cardiac Surgery.
The primary endpoint was the decrease in infection rate as measured by the proportion of subjects with at least one identified sternal infection, DSWI (Deep sternal wound infections) and SSWI (Superficial Sternal Wound Infection) within 90 days of post-cardiac surgery. One patient in the Control arm had an SSWI on day 6 post-surgery. The infection was confirmed by a bacteriology test positive for Proteus mirabilis. No subjects in the D-PLEX treatment arm experienced any sternal wound infections and no infection was confirmed during 90 days post-surgery.
Time frame: Within 90 days post-cardiac surgery.
Decrease in the Number of Readmissions Due to Sternal Surgical Site Infection
No readmissions due to sternal surgical site infections were reported in any treatment arm.
Time frame: Within 90 days post-cardiac surgery.
Decrease in Number of Surgical Re-interventions Due to Sternal Surgical Site Infection.
No surgical re-interventions due to sternal surgical site infections were required in any treatment arm.
Time frame: Within 90 days post-cardiac surgery.
Time to Sternal Infection Post-cardiac Surgery.
Only one subject in the Control arm group had an sternal infection on day 6 post cardiac surgery.
Time frame: Within 90 days post-cardiac surgery.
Decrease of Sternal Infection Rate, DSWI (Deep Sternal Wound Infections) and SSWI (Superficial Sternal Wound Infection) During the First 30 Days Post Operation.
One subject in the Control arm group had a Sternal Infection during the first 30 days after surgery. None of the subjects in the D-PLEX+SOC (Treatment arm) group had any sternal infection during this period.
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Time frame: Within 30 days post operation.
Decrease in the Total Number of Sternal Infections, DSWI (Deep Sternal Wound Infections) and SSWI (Superficial Sternal Wound Infection) Between Day 30 and 3 Months.
No sternal surgical site infections were reported in any treatment arm between Day 30 and 90 days after the surgery.
Time frame: Between day 30 and 3 months.
Decrease in the Number of Hospitalization Days Due to Sternal Surgical Site Infection.
No hospitalizations due to sternal surgical site infections were reported during the study.
Time frame: Within 90 days post-cardiac surgery.