Surgical Site InfectionPhase 3NCT03558984
D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
A Phase 3 study testing D-PLEX in people with Surgical Site Infection and Sternal Infection, run by PolyPid Ltd. at 3 sites in 2 countries.
Trial summary
Prospective, Multinational, Multicenter, Randomized, Parallel Controlled, Two arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SOC) IV Prophylactic Antibiotic Treatment vs. SOC in Prevention of Post-Cardiac Surgery Sternal Infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection, Sternal Infection, Cardiac Surgery
- What is being tested?
- D-PLEX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 17 Dec 2019to 24 Oct 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects scheduled to elective and/or urgent median sternotomy for cardiac surgery, who are preoperative hemodynamically stable.
- Males and females.
- Subjects age of 18 and older.
- Subjects with both Diabetes Mellitus AND BMI≥30 OR
- Diabetes Mellitus/BMI≥30 AND at least one of the following:
- Current/Previous smoking history ≥30 pack year
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- Chronic Obstructive Pulmonary Disease (COPD)
- 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.
- 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.
Who cannot join
- Subjects undergoing partial sternotomy.
- Subjects with any preoperative active significant infection.
- Subjects that received oral or IV doxycycline during the last 4 weeks prior to screening.
- Subjects with sensitivity to doxycycline and/or to tetracycline family of drugs and/or other study drug ingredients.
- Subjects with known allergies to more than 3 substances. (An allergy questionnaire will be filled during the screening process).
- 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.
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- Subjects with uncontrolled Asthma (GINA III-IV).
- Subjects with chronic urticaria.
- Immunocompromised subjects from any reason, at screening.
- Subjects with renal failure requiring dialysis.
- Subjects scheduled to major organ transplantation and/or to other significant concomitant surgical procedure.
- Subjects scheduled for mechanical assist device.
- Subjects scheduled to be treated with preventive negative pressure devices.
- Subjects undergone Cerebro-Vascular Accident (CVA)/Transient Ischemic Attack (TIA) within the past 3 months prior to randomization.
- Subjects that have undergone previously, any cardiac surgery through sternotomy.
- Subjects with active or previous malignancy in the chest area.
- 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.
- Pregnant or breast-feeding women or women of childbearing age not protected by an effective contraceptive method of birth control (such as double barrier, oral or parenteral hormonal, intrauterine device and spermicide).
- 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).
- 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 Follow-Up visits attendance etc.).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Memorial Hermann
Huston, Texas, 77024
Mayo Clinic
Rochester, Minnesota, 55902
About this study
Official title: Prospective, Multicenter, Randomized, Parallel Controlled, Two Arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly With the SOC IV Prophylactic Antibiotic Treatment vs. SOC in Prevention of Post-Cardiac Surgery Sternal Infections
Prospective, Multinational, Multicenter, Randomized, Parallel Controlled, Two arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SOC) IV Prophylactic Antibiotic Treatment vs. SOC in Prevention of Post-Cardiac Surgery Sternal Infections.
Study to assess D-PLEX efficacy and safety 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.
Read the detailed description
This is Phase III study to evaluate the anti-infective efficacy and safety of D-PLEX, a new formulation of extended release of Doxycycline, over a period of 3 months post operation by preventing sternal infection post cardiac surgery in patients above the age of 18, including high risk patients for infection. Study will be conducted in about 45 sites in US (about 15 sites), Europe and Israel, recruitment period will last about 18 months. D-PLEX will be administered as a single application. For subjects randomized to the investigational treatment arm, D-PLEX treatment will be applied at the end of the index surgery just before closing the chest, as an adjunct to the SOC prophylactic antibiotic treatment. For subjects randomized to the control arm, the surgical treatment will be as per the SOC. Pre- and post-operative care for both arms will be performed per site SOC. Patients will followed-up during 6 months after surgery.
- Conditions
- Surgical Site Infection, Sternal Infection, Cardiac Surgery
- Being tested
- D-PLEX, Standard of Care
- Keywords
- Cardiac, Surgery, Sternotomy, Heart, CABG, Valve-replacement, Aorta-replacement
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-PLEXDrug
D-PLEX is a new formulation of extended release of Doxycycline (active ingredient)
Standard of CareOther
The SOC prophylactic antibiotic treatment will be consistent and standardized for all sites in the clinical study. is based on "The society of thoracic surgeons practice guideline series: antibiotic prophylaxis in cardiac surgery, part II: antibiotic choice."
| Study group | Role | What they receive |
|---|---|---|
| D-PLEX + SOC | Experimental | For subjects randomized to the investigational treatment arm, D-PLEX treatment will be applied at the end of the index surgery just before closing the chest, as an adjunct to the SOC prophylactic antibiotic treatment. Receives: Drug: D-PLEX; Other: Standard of Care |
| Standard of Care | Other | For subjects randomized to the control arm, the surgical treatment will be as per the SOC. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Sternal Wound Infection Event
Sternal infection will be identified by predefined criteria based on modification of the CDC's Criteria for Surgical Site Infection (SSI) \& Surveillance Definition for Specific Types of Infections Chapters, January 2018
Measured: within 90 days (3 months) post sternotomy for cardiac surgery
Secondary outcomes (3)
Hospitalization Days
Number of Hospitalization days post sternotomy due to sternal infection.
Measured: within 90 days (3 months) post sternotomy for cardiac surgery
Surgical Re-interventions
Number of Surgical re-interventions due to sternal surgical site infection.
Measured: 90 days (3 months) post sternotomy
ASEPSIS Assessment Score
ASEPSIS is acronym of wound assessment and treatment parameters, which provides numerically score during an inspection of the surgical site. The final score is being interpreted to severity of wound appearance and the clinical consequences of the infection.
Parameters and Scores: Serous discharge \& Erythema will be marked between 0 - 5. Purulent exudate \& Separation of deep tissue are marked between 0 - 10 - based on the proportion of the wound they affect when 0 is none and either 5 or 10 are for over 80% of the wound. Additional antibiotic treatment, a requirement for pus drainage, isolation of bacteria \& stay duration as an inpatient are scored Yes or No. No equals 0. Yes is calculated as either 5 points (for some parameters) or 10 for others. The final score can be in the range of 0 - 70. 0 - 10 for wound which heals satisfactorily and over 40 for a severe wound infection.
Measured: 90 days (3 month) post sternotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start17 Dec 2019
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Why it stopped: company prioritization reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible subjects will be randomized to either the treatment arm (D-PLEX + SOC prophylactic antibiotic treatment) or to control arm (SOC prophylactic antibiotic treatment only), in a 1:1 ratio. Subjects will be blinded to the study arm.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- PolyPid Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hartzell V. Schaff, M.D., Principal investigator, Mayo Clinic, 220 First Street SW, Rochester, MN. 55902
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558984
- Sponsor's protocol ID
- D-PLEX 302
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2018
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized, Parallel Controlled, Two Arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly With the SOC IV Prophylactic Antibiotic Treatment vs. SOC in Prevention of Post-Cardiac Surgery Sternal Infections
- ClinicalTrials.gov ID
- NCT03558984
- Acronym / sponsor ID
- D-PLEX 302
- Conditions
- Surgical Site Infection, Sternal Infection, Cardiac Surgery
- Keywords
- Cardiac, Surgery, Sternotomy, Heart, CABG, Valve-replacement, Aorta-replacement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: company prioritization reasons
- Enrolment
- 2 participants (actual)
- Lead sponsor
- PolyPid Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, Multinational, Multicenter, Randomized, Parallel Controlled, Two arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SOC) IV Prophylactic Antibiotic Treatment vs. SOC in Prevention of Post-Cardiac Surgery Sternal Infections.
Study to assess D-PLEX efficacy and safety 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.
Detailed description
This is Phase III study to evaluate the anti-infective efficacy and safety of D-PLEX, a new formulation of extended release of Doxycycline, over a period of 3 months post operation by preventing sternal infection post cardiac surgery in patients above the age of 18, including high risk patients for infection. Study will be conducted in about 45 sites in US (about 15 sites), Europe and Israel, recruitment period will last about 18 months. D-PLEX will be administered as a single application. For subjects randomized to the investigational treatment arm, D-PLEX treatment will be applied at the end of the index surgery just before closing the chest, as an adjunct to the SOC prophylactic antibiotic treatment. For subjects randomized to the control arm, the surgical treatment will be as per the SOC. Pre- and post-operative care for both arms will be performed per site SOC. Patients will followed-up during 6 months after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible subjects will be randomized to either the treatment arm (D-PLEX + SOC prophylactic antibiotic treatment) or to control arm (SOC prophylactic antibiotic treatment only), in a 1:1 ratio. Subjects will be blinded to the study arm.
| Arm | Type | Receives |
|---|---|---|
| D-PLEX + SOC | Experimental | Drug: D-PLEX, Other: Standard of CareFor subjects randomized to the investigational treatment arm, D-PLEX treatment will be applied at the end of the index surgery just before closing the chest, as an adjunct to the SOC prophylactic antibiotic treatment. |
| Standard of Care | Other | Other: Standard of CareFor subjects randomized to the control arm, the surgical treatment will be as per the SOC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects scheduled to elective and/or urgent median sternotomy for cardiac surgery, who are preoperative hemodynamically stable.
- Males and females.
- Subjects age of 18 and older.
- Subjects with both Diabetes Mellitus AND BMI≥30 OR
- Female of childbearing potential should have a negative serum pregnancy test prior to index procedure.
Key exclusion criteria (20 listed)
- Subjects undergoing partial sternotomy.
- Subjects with any preoperative active significant infection.
- Subjects that received oral or IV doxycycline during the last 4 weeks prior to screening.
- Subjects with sensitivity to doxycycline and/or to tetracycline family of drugs and/or other study drug ingredients.
- Subjects with known allergies to more than 3 substances. (An allergy questionnaire will be filled during the screening process).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-PLEXD-PLEX is a new formulation of extended release of Doxycycline (active ingredient) | Drug | D-PLEX + SOC |
| Standard of CareThe SOC prophylactic antibiotic treatment will be consistent and standardized for all sites in the clinical study. is based on "The society of thoracic surgeons practice guideline series: antibiotic prophylaxis in cardiac surgery, part II: antibiotic choice." | Other | D-PLEX + SOC, Standard of Care |
Primary outcome
Number of Participants With a Sternal Wound Infection Event
Time frame: within 90 days (3 months) post sternotomy for cardiac surgery
Sternal infection will be identified by predefined criteria based on modification of the CDC's Criteria for Surgical Site Infection (SSI) \& Surveillance Definition for Specific Types of Infections Chapters, January 2018
3 secondary outcomes
Hospitalization Days
Time frame: within 90 days (3 months) post sternotomy for cardiac surgery
Surgical Re-interventions
Time frame: 90 days (3 months) post sternotomy
ASEPSIS Assessment Score
Time frame: 90 days (3 month) post sternotomy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hartzell V. Schaff, M.D. principal investigator
Mayo Clinic, 220 First Street SW, Rochester, MN. 55902
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing D-PLEX in people with Surgical Site Infection and Sternal Infection, run by PolyPid Ltd. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Sternal Wound Infection Event (time frame: within 90 days (3 months) post sternotomy for cardiac surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.