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New gel wipes out infections after heart surgery in early trial

NCT ID NCT02731573

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 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.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

81 people

The number who actually took part.

Started

Oct 2016

Finished

May 2018

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. 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

  • Assuta Medical Center

    Tel Aviv, Israel

  • Poriya Medical Center

    Tiberias, Israel

  • Rambam Medical Center

    Haifa, Israel

  • Sheba Medical Center

    Tel Litwinsky, Israel

  • Soroka Medical Center

    Beersheba, Israel