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

A Phase Ib/II Prospective, Multicenter, Two Part Study; Part 1 - Open Label, Single Arm & Part 2 Randomized, Single-blinded Study to Assess Safety and Efficacy of D-PLEX Concomitantly With Standard of Care vs. Standard of Care Alone in the Prevention of Sternal Infection Post Cardiac Surgery.

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Wound Infection Superficial Incisional; Postoperative Wound Infection Deep Incisional Surgical Site
• Intervention / Treatment: Drug: D-PLEX; Procedure: Open heart surgery

Detailed Description

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
• Enrollment (Actual): 81
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Beersheba, Israel
    • Soroka Medical Center
  • Haifa, Israel
    • Rambam Medical Center
  • Tel Aviv, Israel
    • Assuta Medical Center
  • Tel Litwinsky, Israel
    • Sheba Medical Center
  • Tiberias, Israel
    • Poriya Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or non-pregnant female above 18 years old

2. 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.

3. Subjects undergoing elective or urgent cardiac surgery, who are preoperative stable hemodynamically.
4. Subjects with (20≤BMI≤40)
5. Subjects who sign a written informed consent.

Exclusion Criteria:

1. 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).

2. 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
3. Pregnant or breastfeeding women.
4. Subjects who have taken oral or IV doxycycline during the last 4 weeks prior to screening.
5. Subjects who undergo cardiac/open chest surgeries, which are classified as emergency.
6. Immunocompromised subjects from any reason, at screening.
7. Subjects that undergone TIA/ CVA within the last 3 months prior to enrollment.
8. Subjects that previously underwent any cardiac surgery through mid-sternum.
9. 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: D-PLEX + SoC; Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care with treatment by D-PLEX.	Drug: D-PLEX; 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.; Procedure: Open heart surgery; Subject will undergo open heart surgery according to standard of care; Other Names: SOC
Other: Standard of Care (SoC); Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care.	Procedure: Open heart surgery; Subject will undergo open heart surgery according to standard of care; Other Names: SOC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 90 days post-cardiac surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Within 90 days post-cardiac surgery.

Collaborators and Investigators

• Sponsor: PolyPid Ltd.
• Investigators: Principal Investigator: Erez V. Kachel, MD, Sheba MC

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: March 24, 2016
• First Submitted That Met QC Criteria: April 6, 2016
• First Posted (Estimated): April 7, 2016

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Mediastenitis; prevention of surgical site infection (SSI)
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: D-PLEX -301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No