New gel wipes out infections after heart surgery in early trial
NCT ID NCT02731573
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new treatment called D-PLEX to prevent serious wound infections after heart surgery. 81 adults, including those at high risk, received either D-PLEX plus standard care or standard care alone. Over 90 days, no one who got D-PLEX developed a sternal infection, while one person in the standard care group did.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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81 people
The number who actually took part.
- Started
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Oct 2016
- Finished
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May 2018
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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. Male or non-pregnant female above 18 years old 2. 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. 3. Subjects undergoing elective or urgent cardiac surgery, who are preoperative stable hemodynamically. 4. Subjects with (20≤BMI≤40) 5. Subjects who sign a written informed consent. Exclusion Criteria: 1. 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). 2. 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 3. Pregnant or breastfeeding women. 4. Subjects who have taken oral or IV doxycycline during the last 4 weeks prior to screening. 5. Subjects who undergo cardiac/open chest surgeries, which are classified as emergency. 6. Immunocompromised subjects from any reason, at screening. 7. Subjects that undergone TIA/ CVA within the last 3 months prior to enrollment. 8. Subjects that previously underwent any cardiac surgery through mid-sternum. 9. 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)
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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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Assuta Medical Center
Tel Aviv, Israel
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Poriya Medical Center
Tiberias, Israel
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Rambam Medical Center
Haifa, Israel
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Sheba Medical Center
Tel Litwinsky, Israel
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Soroka Medical Center
Beersheba, Israel