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New gel could slash infection risk after abdominal surgery

NCT ID NCT04411199

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

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study tests whether a gel called D-PLEX, which slowly releases the antibiotic doxycycline, can prevent surgical site infections in people undergoing colorectal or abdominal surgery. About 975 participants will receive either D-PLEX plus standard care or standard care alone. The main goal is to see if D-PLEX reduces the number of infections within 30 days after surgery.

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 the risk of serious wound infections after abdominal surgery, potentially improving recovery and reducing hospital stays.
What could go wrong
This is a phase 3 trial, but results may not confirm benefit. Risks include side effects from doxycycline or no reduction in infection rates compared to 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

975 people

The number who actually took part.

Started

Dec 2020

Finished

May 2025

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 \>20cm (target incision). 2. Subjects are preoperative hemodynamically stable. (BP≤180/110 and \>90/60 mmHg, and HR≤120 and \>60 bpm, and temperature ≤37.50C and \>35.50C). 3. Male or non-pregnant female. 4. Female of child-bearing potential should have a negative pregnancy test (serum or urine dipstick) 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 sixty 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, etc.) 2. Subjects who underwent an intra-abdominal surgery within the last six months prior to randomization. 3. Subjects with any preoperative active infection or who are receiving any antibiotic therapy in the past one week prior to randomization, excluding pre-operative prophylaxis or antibiotics for the treatment of the disease that is the indication for surgery. 4. Subjects undergoing concomitant major procedures in addition to the colorectal resection. Female sterilization surgeries (i.e. salpingo-oophorectomy etc.), involvement of a small bowel procedure or cholecystectomy may be allowed, pending an advanced consultation and approval from the Sponsor. 5. Subjects who received any anti-cancer treatment within the last four weeks of surgery. 6. Subjects who received radiation for colorectal cancer to the abdomen and/or pelvis area, within the last four weeks of the planned abdominal surgery. 7. Subjects who received oral or IV Doxycycline or Tetracycline family antibiotics during the past four 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 three substances. 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. Uncontrolled medical condition. 12. 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 three years. 13. Any subject with an active malignancy or with malignancy that has not been in complete clinical remission and without maintenance chemo or immunotherapy for at least three years.

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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

  • Assaf Harofeh Medical Center

    Ẕerifin, 70300, Israel

  • Augusta Univeristy

    Augusta, Georgia, 30912, United States

  • Bajai Szent Rokus Korhaz, Sebeszeti Osztaly

    Baja, 6500, Hungary

  • Baylor University Medical Center

    Dallas, Texas, 75246, United States

  • Bnai Zion Medical Center

    Haifa, 3339419, Israel

  • Bugát Pál Kórház, Gasztroenterológia - Sebészet

    Gyöngyös, 3200, Hungary

  • Bács-Kiskun Megyei Kórház

    Kecskemét, 6000, Hungary

  • Cantonal Hospital Zenica

    Zenica, 72000, Bosnia and Herzegovina

  • Carmel Medical Center

    Haifa, 3436212, Israel

  • Centro Clinico Academico de Braga Associação - Hospital de Braga

    Braga, 4710-243, Portugal

  • Centrum Medyczne Med-Gastr

    Lodz, 91-034, Poland

  • Fejer-County Saint George University Teaching Hospital, Department of Surgery

    Székesfehérvár, 8000, Hungary

  • First Surgical Clinic

    Belgrade, 11000, Serbia

  • Galilee Medical Center

    Nahariya, 2210001, Israel

  • General Hospital Sremska Mitrovica

    Sremska Mitrovica, 22000, Serbia

  • Health Center Valjevo

    Valjevo, 14000, Serbia

  • Heves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet Sebeszeti es Ersebeszeti osztaly

    Eger, 3300, Hungary

  • IMSP Clinical republican Hospital "Timofei Mosneaga"

    Chisinau, MD2025, Moldova

  • IMSP Institutul de Medicina Urgenta

    Chisinau, MD2004, Moldova

  • IMSP Institutul of Oncologic

    Chisinau, MD2025, Moldova

  • IMSP Spitalul Clinic Municipal "Gheorghe Paladi"

    Chisinau, MD2038, Moldova

  • IMSP Spitalul Clinic Municipal "Sfanta Treime"

    Chisinau, MD2068, Moldova

  • IMSP Spitalul Clinic Republican "Timofei Mosneaga"

    Chisinau, MD2025, Moldova

  • Kaplan Medical Center

    Rehovot, 7661041, Israel

  • LLC American Hospital Network

    Tbilisi, 0102, Georgia

  • LTD "Israeli - Georgian Medical Research Clinic Healthycore"

    Tbilisi, 0112, Georgia

  • LTD Multiprofile Clinic Consillium Medulla

    Tbilisi, 0186, Georgia

  • LTD New Hospitals

    Tbilisi, 0114, Georgia

  • Mures County Clinical Hospital

    Târgu Mureş, 540103, Romania

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121, United States

  • Oncology Institute of Vojvodina

    Kamenitz, 21204, Serbia

  • Our Lady of Lourdes Hospital

    Drogheda, A92 VW28, Ireland

  • PHI Clinical Hospital - Shtip

    Skopje, 2000, North Macedonia

  • PHI General Hospital "Borka Taleski" Prilep

    Prilep, 7500, North Macedonia

  • PHI General Hospital - Strumica

    Strumica, 2400, North Macedonia

  • PHI University Clinic for Surgical Diseases "st.Naum Ohridski - Skopje"

    Skopje, 1000, North Macedonia

  • PHI University Clinic for digestive Surgery

    Skopje, 1000, North Macedonia

  • Penn State Health Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Pest Megyei Flór Ferenc Kórház Sebészeti Osztály

    Kistarcsa, 2143, Hungary

  • Sf. Constantin Hospital

    Brasov, 500388, Romania

  • Shaare Zedek Medical Center

    Jerusalem, 9372212, Israel

  • Sheba Medical Center

    Ramat Gan, 5262000, Israel

  • Soroka Medical Center

    Beersheba, 8457108, Israel

  • Spitalul Clinic JudeIean de Urgenta "Pius Brinzeu", Sectia Chirurgie Generala II

    Timișoara, 300723, Romania

  • Spitalul Clinic Judetean de Urgenta Craiova, Sectia Cbirurgie Generala II

    Craiova, 200642, Romania

  • Spitalul Clinic Judetean de Urgenta Craiova, Sectia Chirurgie Generala III

    Craiova, 200642, Romania

  • Szabolcs-Szatmar-Bereg Varmegyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz, Sebeszeti Osztaly

    Nyíregyháza, 4400, Hungary

  • Szpital Powiatowy im. Marii Skłodowskiej - Curie w Ostrowie Mazowieckiej SPZZOZ

    Ostrów Mazowiecka, 07-300, Poland

  • UCC Nis

    Niš, 18000, Serbia

  • Unidade Local de Saúde da Região de Aveiro E. P. E.

    Aveiro, 3810-164, Portugal

  • Unidade de Saúde Local da Guarda

    Guarda, 6300-749, Portugal

  • University Clinical Center Tuzla

    Tuzla, 75000, Bosnia and Herzegovina

  • University Clinical Centre of the Republic of Srpska

    Banja Luka, 78000, Bosnia and Herzegovina

  • University Hospital Erlangen

    Erlangen, 91054, Germany

  • University of Muenster

    Münster, 48149, Germany

  • University of Szeged, Faculty of Medicine, Dep.of Surgery

    Szeged, 6725, Hungary

  • Uzsoki Utcai Kórház, Sebészeti Osztály

    Budapest, 1145, Hungary

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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