Postoperative Wound Infection Superficial IncisionalPhase 1/2NCT02731573
Safety and Efficacy of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery.
A Phase 1/2 study testing D-PLEX and Open heart surgery in people with Postoperative Wound Infection Superficial Incisional and Postoperative Wound Infection Deep Incisional Surgical Site, run by PolyPid Ltd. at 5 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Wound Infection Superficial Incisional, Postoperative Wound Infection Deep Incisional Surgical Site
- What is being tested?
- D-PLEX and Open heart surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 5 sitesIsrael
- Study dates
- 12 Oct 2016to May 2018
- Phase
- Phase 1/2
- 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
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Israel5 sites
Soroka Medical Center
Beersheba
Rambam Medical Center
Haifa
Assuta Medical Center
Tel Aviv
Sheba Medical Center
Tel HaShomer
Poriya Medical Center
Tiberias
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Wound Infection Superficial Incisional, Postoperative Wound Infection Deep Incisional Surgical Site
- Being tested
- D-PLEX, Open heart surgery
- Keywords
- Mediastenitis, prevention of surgical site infection (SSI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-PLEXDrug
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.
Open heart surgeryProcedure or surgery
Also called SOC
Subject will undergo open heart surgery according to standard of care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Open heart surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 90 days post-cardiac surgery.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 90 days post-cardiac surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study start12 Oct 2016
- Primary completionFeb 2018
- Study completionMay 2018
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 Postoperative Wound Infection Superficial IncisionalStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- PolyPid Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erez V. Kachel, MD, Principal investigator, Sheba MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731573
- Sponsor's protocol ID
- D-PLEX -301
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2016
- Last updated
- 13 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02731573
- Acronym / sponsor ID
- D-PLEX -301
- Conditions
- Postoperative Wound Infection Superficial Incisional, Postoperative Wound Infection Deep Incisional Surgical Site
- Keywords
- Mediastenitis, prevention of surgical site infection (SSI)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- PolyPid Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Oct 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 7 Apr 2016 (estimated)
- Results
- Posted 13 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| D-PLEX + SoC | Experimental | Drug: D-PLEX, Procedure: Open heart surgerySubjects 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. |
| Standard of Care (SoC) | Other | Procedure: Open heart surgerySubjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (15 listed)
- 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:
- 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.
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 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. | Drug | D-PLEX + SoC |
| Open heart surgeryAlso: SOCSubject will undergo open heart surgery according to standard of care | Procedure or surgery | D-PLEX + SoC, Standard of Care (SoC) |
Primary outcome
Decrease of Infection Rate as Measured by the Proportion of Subjects With at Least 1 Identified Sternal Infection Within 90 Days Post-cardiac Surgery.
Time frame: 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.
6 secondary outcomes
Decrease in the Number of Readmissions Due to Sternal Surgical Site Infection
Time frame: Within 90 days post-cardiac surgery.
Decrease in Number of Surgical Re-interventions Due to Sternal Surgical Site Infection.
Time frame: Within 90 days post-cardiac surgery.
Time to Sternal Infection 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.
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.
Time frame: Between day 30 and 3 months.
Decrease in the Number of Hospitalization Days Due to Sternal Surgical Site Infection.
Time frame: Within 90 days post-cardiac surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Erez V. Kachel, MD principal investigator
Sheba MC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing D-PLEX and Open heart surgery in people with Postoperative Wound Infection Superficial Incisional and Postoperative Wound Infection Deep Incisional Surgical Site, run by PolyPid Ltd. at 5 sites in Israel.
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 6 inclusion and 15 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: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 13 Apr 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?
Decrease of Infection Rate as Measured by the Proportion of Subjects With at Least 1 Identified Sternal Infection Within 90 Days Post-cardiac Surgery. (time frame: Within 90 days post-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 13 Apr 2026.