New antibiotic coating could shield heart surgery patients from dangerous infections
NCT ID NCT03558984
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
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Dec 2019
- Finished
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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
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mayo Clinic
Rochester, Minnesota, 55902, United States
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Memorial Hermann
Huston, Texas, 77024, United States
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Soroka Medical Center
Beersheba, Israel
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Minute-by-Minute urine tracking may sharpen fluid care after heart surgery