Phase 2
N=81
Safety and Efficacy of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery.
Postoperative Wound Infection Superficial Incisional · Postoperative Wound Infection Deep Incisional Surgical Site
Bottom Line
View on ClinicalTrials.gov: NCT02731573 ↗Enrolled (actual)
81
Serious AEs
42.0%
Results posted
Apr 2026
Primary outcome: Primary: Decrease of Infection Rate as Measured by the Proportion of Subjects With at Least 1 Identified Sternal Infection Within 90 Days Post-cardiac Surgery. — 0; 4.8 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- D-PLEX (Drug); Open heart surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- PolyPid Ltd.
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decrease of Infection Rate as Measured by the Proportion of Subjects With at Least 1 Identified Sternal Infection Within 90 Days Post-cardiac Surgery. |
0; 4.8 | — |
| SECONDARY Decrease in the Number of Readmissions Due to Sternal Surgical Site Infection |
0; 0 | — |
| SECONDARY Decrease in Number of Surgical Re-interventions Due to Sternal Surgical Site Infection. |
0; 0 | — |
| SECONDARY Time to Sternal Infection Post-cardiac Surgery. |
0; 6 | — |
| SECONDARY Decrease of Sternal Infection Rate, DSWI (Deep Sternal Wound Infections) and SSWI (Superficial Sternal Wound Infection) During the First 30 Days Post Operation. |
0; 1 | — |
| SECONDARY 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. |
0; 0 | — |
| SECONDARY Decrease in the Number of Hospitalization Days Due to Sternal Surgical Site Infection. |
0; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Male or non-pregnant female above 18 years old
- 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 (such as double barrier, oral or parenteral hormonal, intrauterine device and spermicide) consistently and correctly for the duration of the study.
- Subjects undergoing elective or urgent cardiac surgery, who are preoperative stable hemodynamically.
- Subjects with (20≤BMI≤40)
- Subjects who sign a written informed consent.
Exclusion Criteria
- Received any investigational drug within 30 days of start of study or within 5½ half-lives (pharmacokinetic or pharmacodynamics) prior to enrollment (whichever is longer).
- Are ineligible to receive treatment with:
- Any preoperative active significant infection
- Antibiotic sensitivity to Doxycycline and/or tetracycline family of drugs
- Known allergies to more than 3 substances.(Patients should fill the allergy questioners during the enrolment process)
- 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.
- History of uncontrolled Asthma (GINA III-IV)
- History of chronic urticaria
- Pregnant or breastfeeding women.
- Subjects who have taken oral or IV doxycycline during the last 4 weeks prior to screening.
- Subjects who undergo cardiac/open chest surgeries, which are classified as emergency.
- Immunocompromised subjects from any reason, at screening.
- Subjects that undergone TIA/ CVA within the last 3 months prior to enrollment.
- Subjects that previously underwent any cardiac surgery through mid-sternum.
- In the opinion of investigator, subject is not eligible to participate in the study due to a cognitive status, medical condition or medication status (other than items listed above)
Data sourced from ClinicalTrials.gov (NCT02731573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.