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New antibiotic coating could shield heart surgery patients from dangerous infections

NCT ID NCT03558984

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This trial tests whether D-PLEX, an extended-release form of the antibiotic doxycycline, can prevent sternal wound infections in people at high risk after cardiac surgery. Participants receive D-PLEX along with standard intravenous antibiotics, or standard antibiotics alone. The study tracks infections, hospital stays, and any need for repeat surgery over 90 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
D-PLEX (extended-release doxycycline)
What this could lead to
If effective, D-PLEX could reduce serious sternal infections after heart surgery, shortening hospital stays and avoiding repeat operations.
What could go wrong
This is an early-stage trial with only 2 participants enrolled, so results may not apply broadly. The treatment may not prevent infections better than standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

2 people

The number who actually took part.

Started

Dec 2019

Finished

Oct 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects scheduled to elective and/or urgent median sternotomy for cardiac surgery, who are preoperative hemodynamically stable. 2. Males and females. 3. Subjects age of 18 and older. 4. 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 * Chronic Obstructive Pulmonary Disease (COPD) 5. 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. 6. 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. Exclusion Criteria: 1. Subjects undergoing partial sternotomy. 2. Subjects with any preoperative active significant infection. 3. Subjects that received oral or IV doxycycline during the last 4 weeks prior to screening. 4. Subjects with sensitivity to doxycycline and/or to tetracycline family of drugs and/or other study drug ingredients. 5. Subjects with known allergies to more than 3 substances. (An allergy questionnaire will be filled during the screening process). 6. 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. 7. Subjects with uncontrolled Asthma (GINA III-IV). 8. Subjects with chronic urticaria. 9. Immunocompromised subjects from any reason, at screening. 10. Subjects with renal failure requiring dialysis. 11. Subjects scheduled to major organ transplantation and/or to other significant concomitant surgical procedure. 12. Subjects scheduled for mechanical assist device. 13. Subjects scheduled to be treated with preventive negative pressure devices. 14. Subjects undergone Cerebro-Vascular Accident (CVA)/Transient Ischemic Attack (TIA) within the past 3 months prior to randomization. 15. Subjects that have undergone previously, any cardiac surgery through sternotomy. 16. Subjects with active or previous malignancy in the chest area. 17. 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. 18. 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). 19. 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). 20. 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.).

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Conditions

The condition(s) this trial relates to.

Surgical Wound Infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Mayo Clinic

    Rochester, Minnesota, 55902, United States

  • Memorial Hermann

    Huston, Texas, 77024, United States

  • Soroka Medical Center

    Beersheba, Israel

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