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New antibiotic gel aims to stop surgical infections in their tracks

NCT ID NCT04233424

Prevention Sponsor: PolyPid Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This large Phase 3 trial tested a new antibiotic gel called D-PLEX, which is placed into the surgical wound during abdominal surgery to slowly release the antibiotic doxycycline over time. The goal was to see if it could prevent surgical site infections better than standard care alone. Nearly 1,000 adults undergoing elective colorectal surgery took part in the study across multiple countries.

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 successful, D-PLEX could provide a new way to prevent infections after abdominal surgery, reducing complications and hospital stays.
What could go wrong
This is a completed Phase 3 trial, but results are not yet public. The treatment may not prove significantly better than standard care, and there could be side effects from the antibiotic.

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

977 people

The number who actually took part.

Started

Jun 2020

Finished

Sep 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 to 99 years

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 undergoing an elective colorectal surgery involving resection, with or without a stoma formation, that includes at least 1 abdominal incision that is \> 10cm (target incision). 2. Subjects are preoperative hemodynamically stable 3. Male or non-pregnant female. 4. Female of child-bearing potential should have a negative pregnancy test prior to index procedure. 5. Subjects' age 18 years old and above at screening. 6. Subjects who sign the written Informed Consent Form. 7. Subjects who are willing and able to participate and meet all study requirements. 8. Survival expectancy of at least 60 days post randomization EXCLUSION CRITERIA 1. Subjects with suspected/diagnosed intestinal perforation, intra-abdominal abscess, or any emergency/urgent colorectal surgery with acute intestinal obstruction (ex. toxic colitis, ileus/sub-ileus, megacolon, diverticulitis, volvulus, ect.) 2. Subjects who underwent an intra-abdominal surgery within the last 6 months prior to randomization. 3. Subjects with any preoperative active infection or who are receiving any antibiotic therapy in the past 1 week prior to randomization, excluding pre-operative prophylaxis. 4. Subjects undergoing concomitant major procedures in addition to the abdominal surgery, including concomitant repair of ventral hernia. Salpingo-oophorectomy and cholecystectomy are allowed. 5. Subjects who received any anti-cancer treatment within the last 4 weeks of surgery. 6. Subjects who received radiation for colorectal cancer to the abdomen area, prior to the planned abdominal surgery. 7. Subjects who received oral or IV Doxycycline or Tetracycline family antibiotics during the past 4 weeks prior to randomization. 8. Subjects with known allergy to Doxycycline and/or to the tetracycline family of drugs or to the D-PLEX's excipients. 9. Subjects with known allergies to more than 3 substances (an allergy questionnaire will be completed during the screening process). 10. Subjects with history of severe allergic reaction to any substance, having required treatment with intravenous steroids/intramuscular epinephrine, or who in the opinion of the PI is at high risk of developing severe allergic reactions. 11. Subjects with End Stage Renal Disease (ESRD/ CKD stage 5). 12. Subjects with severe hepatic impairment. 13. Subjects with chronic urticaria. 14. Subjects diagnosed with CVA within the past 6 months prior to randomization. 15. Subjects who underwent any abdominal surgery and current planned index surgery involves re-opening the scar of a prior abdominal surgery performed within the last 3 years. 16. Any subject with an active malignancy, other than resectable non-metastatic colorectal cancer, that is the reason for the index surgery, or carcinoma in situ (or other cancer "in situ = Stage 0"), or squamous cell carcinoma of the skin, or basal cell carcinoma of the skin, or a malignancy that has not been in complete clinical remission and without maintenance chemo or immunotherapy for at least 3 years. 17. Subjects with other concurrent severe and/or uncontrolled medical conditions. 18. Psychiatric or any other disorder that compromises ability to provide informed consent for participation in this study. 19. Chronic alcoholic or drug abuse subjects. 20. Pregnant or breast-feeding women or women of child-bearing age who refuse or are prohibited of using an effective contraceptive method of birth control throughout study participation, including the safety follow-up period. 21. Subjects who received any investigational drug within 30 days or 5 half-lives prior to randomization to the study (whichever is longer) and through the study. 22. Subjects participating in any other interventional study. 23. Subjects, who in the opinion of Investigator, are not eligible to participate in the study and/or to comply with the protocol requirements (e.g. due to a cognitive or medical condition).

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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.

Abdominal surgery Colon surgery Post-op infection Surgical site infection

Contacts and locations

Locations

  • "IV Multiprofile Hospital for Active Treatment - Sofia" EAD

    Sofia, 1606, Bulgaria

  • "MHAT Sveta Caridad" EAD

    Plovdiv, 4004, Bulgaria

  • "Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski - 2003" OOD

    Dupnitsa, 2600, Bulgaria

  • "Multiprofile Hospital for Active Treatment "Sveti Panteleymon"-Yambol AD

    Yambol, 8600, Bulgaria

  • "Multiprofile Hospital for Active Treatment - Blagoevgrad" AD

    Blagoevgrad, 2700, Bulgaria

  • "Multiprofile Hospital for Active Treatment - Haskovo" AD

    Haskovo, 6304, Bulgaria

  • "Multiprofile Hospital for Active Treatment - Uni Hospital" OOD

    Panagyurishte, 4500, Bulgaria

  • "Multiprofile Regional Hospital for Active Treatment "Dr. St. Cherkezov"" AD

    Veliko Tarnovo, 5002, Bulgaria

  • "Prof. Dr. Octavian Fodor"

    Cluj-Napoca, 400162, Romania

  • "Sf. Constantin" Hospital

    Brasov, 500388, Romania

  • "University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov" EAD

    Sofia, 1606, Bulgaria

  • Assuta Medical center

    Tel Aviv, Israel

  • Bajai Szent Rókus Kórház, Sebészeti Osztály

    Baja, Bács-Kiskun Megye, 6500, Hungary

  • Békés-Megyei Központi Kórház, I. Sebészeti Osztály

    Gyula, 5600, Hungary

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Coltea Clinical Hospital, Department of General Surgery

    Bucharest, 30171, Romania

  • Complex Oncology Center - Vratsa - EOOD

    Vratsa, 3000, Bulgaria

  • County Emergency Clinical Hospital Craiova, Department of General Surgery I

    Craiova, 200642, Romania

  • County Emergency Clinical Hospital Craiova, Department of General Surgery II

    Craiova, 200642, Romania

  • County Emergency Clinical Hospital Craiova, Department of General Surgery III

    Craiova, 200642, Romania

  • County Emergency Clinical Hospital Timisoara "Pius Brînzeu"

    Timișoara, 300723, Romania

  • Csongrad-Csanad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely - Mako, Sebeszeti Osztaly

    Hódmezővásárhely, 6800, Hungary

  • Department - Surgery, "Multiprofile Hospital for Active Treatment - Hristo Botev" AD

    Vratsa, 3001, Bulgaria

  • Emergency University Hospital Elias, Clinical Department of General Surgery

    Bucharest, 11461, Romania

  • FNsP J.A. Reimana Presov Oddelenie chirurgie

    Prešov, 081 81, Slovakia

  • Fakultna nemocnica s poliklinikou Zilina Oddelenie chirurgie

    Žilina, 01001, Slovakia

  • Fakultni Nemocnice Brno Chirurgicka klinika

    Brno, 62500, Czechia

  • Fakultni nemocnice Kralovske Vinohrady Chirurgicka klinika

    Prague, 100 34, Czechia

  • Fejér Megyei Szent György Egyetemi Oktató Kórház, Sebészeti Osztály

    Székesfehérvár, 8000, Hungary

  • Galilee Medical Center

    Nahariya, Nahariya-Cabri, 22100, Israel

  • General Hospital Zadar

    Zadar, 23000, Croatia

  • IMSP Clinical Republican Hospital "Timofei Mosneaga"

    Chisinau, 2025, Moldova

  • IMSP Institute of Emergency Medicine

    Chisinau, 2004, Moldova

  • IMSP Institute of Oncology

    Chisinau, 2025, Moldova

  • IMSP Municipal Clinical Hospital "Sfanta Treime"

    Chisinau, 2068, Moldova

  • KBC Rijeka

    Rijeka, 51000, Croatia

  • KBC Sestre milosrdnice Klinika za tumore

    Zagreb, 10000, Croatia

  • Kaplan Medical Center

    Rehovot, Pasternak, 76100, Israel

  • Krajska nemocnice Liberec, a. s.

    Liberec, 46001, Czechia

  • Medical Center Dr.Ianosi, Department of Surgery

    Craiova, 200061, Romania

  • Nemocnice Na Bulovce

    Prague, 18081, Czechia

  • Oddzial Chirurgii Ogolnej i Onkologicznej, Szpital Uniwersytecki im.Karola Marcinkowskiego

    Zielona Góra, 65-046, Poland

  • Oddzial Kliniczny Chirurgii Onkologicznej, Bydgoszczy

    Bydgoszcz, 85-796, Poland

  • Orosházi Kórház, Invazív Mátrix Sebészet

    Orosháza, 5900, Hungary

  • PMSI Municipal Clinical Hospital No. 1 "Gheorghe Paladi" Department of General Surgery

    Chisinau, MD-2001, Moldova

  • Paradigm Clinical Research Center

    Redding, California, 96001, United States

  • Pécsi Tudományegyetem, Klinikai Központ, Sebészeti Klinika

    Pécs, 7624, Hungary

  • Rabin Medical Center

    Petah Tikva, Israel

  • Semmelweis Egyetem Altalanos Orvostudomanyi Kar, Sebeszeti es Intervencios Gasztroenterologiai

    Budapest, 1082, Hungary

  • Shamir (Assaf-Harofeh) Medical Center

    Zrifin, Israel

  • Shoals Medical Trials

    Sheffield, Alabama, 35660, United States

  • Somogy Megyei Kaposi Mór Oktató Kórház, Sebészeti Osztály

    Kaposvár, 7400, Hungary

  • Sourasky Medical Center

    Tel Aviv, Israel

  • Spitalul Clinic Judetean de Urgentã Targu-Mures

    Craiova, 200642, Romania

  • Summit Medical Group

    Bend, Oregon, 97701, United States

  • Szpital Skawina Sp. z o.o., im. Stanley Dudricka

    Skawina, 32-050, Poland

  • Szpital Specjalistyczny im. Zeromskiego,Oddzial Chirurgii Ogolnej Onkologicznej i Maloinwazyjnej

    Krakow, 31-913, Poland

  • The Chaim Sheba Medical Center

    Ramat Gan, Derech Sheba 2, Israel

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • University First Multiprofile Hospital for Active Treatment - Sofia Sv. Yoan Krastitel EAD

    Sofia, 1154, Bulgaria

  • University Hospital Centre Zagreb (KBC Rebro)

    Zagreb, 10000, Croatia

  • Vseobecna Nemocnica s Poliklinikou Lucenec Chirurgicke Oddelenie

    Lučenec, 98401, Slovakia

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Other studies related to the condition(s) this trial covers.