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

NCT02731573 | Completed Phase 1 Results DMC

• 1 other identifier: D-PLEX -301
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Postoperative Wound Infection Superficial Incisional; Postoperative Wound Infection Deep Incisional Surgical Site

Keywords

Mediastenitis; prevention of surgical site infection (SSI)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Decrease in the Number of Readmissions Due to Sternal Surgical Site Infection

  Within 90 days post-cardiac surgery.

• Decrease in Number of Surgical Re-interventions Due to Sternal Surgical Site Infection.

  Within 90 days post-cardiac surgery.

• Time to Sternal Infection 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.

  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.

  Between day 30 and 3 months.

Study Arms (2)

D-PLEX + SoC

EXPERIMENTAL

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; Procedure: Open heart surgery

Standard of Care (SoC)

OTHER

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

Interventions

D-PLEX DRUG

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.

D-PLEX + SoC

Open heart surgery PROCEDURE

Subject will undergo open heart surgery according to standard of care

Also known as: SOC

D-PLEX + SoC; Standard of Care (SoC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• PolyPid Ltd.: lead

Study Sites (5)

Soroka Medical Center

Beersheba, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

Assuta Medical Center

Tel Aviv, Israel

Location

Sheba Medical Center

Tel Litwinsky, Israel

Location

Poriya Medical Center

Tiberias, Israel

Location

Results Point of Contact

• Title: VP Clinical Affairs
• Organization: PolyPid

eyal.s@polypid.com

+972-74-7195700

Study Officials

• Erez V. Kachel, MD

  Sheba MC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase Ib/II, Prospective, Multicenter, Two part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone. Study population include subjects above the age of 18 years, that undergoing cardiac surgery through mid-sternotomy, including patients with high risk of infection, such as diabetes (Insulin and/or non-insulin dependent), patients with Peripheral Vascular Disease (PVD), Chronic Obstructive Pulmonary Disease (COPD), heavy smokers, Bilateral Mammary artery harvesting, and subjects administered chronic steroid treatment. 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 (part 1) or randomized 2:1 to D-PLEX concomitantly with standard of care vs. standard of care only (part 2).

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: April 7, 2016
• Study Start: October 12, 2016
• Primary Completion: February 1, 2018
• Study Completion: May 1, 2018
• Last Updated: April 13, 2026
• Results First Posted: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (5)