Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Preventing Infections After Abdominal Surgery Using D-PLEX with Doxycycline Hyclate for Patients Undergoing Abdominal Surgery

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on preventing infections that can occur after abdominal surgery, specifically at the site where the incision is made. The study is investigating a treatment called D-PLEX, which is a type of medication that comes in the form of a powder that is turned into a paste and implanted at the surgical site. The active ingredient in D-PLEX is doxycycline hyclate, a chemical substance known for its ability to fight bacteria. The trial aims to see how effective and safe D-PLEX is when used alongside the usual care provided after surgery, compared to the usual care alone.

Participants in the study will be randomly assigned to one of two groups. One group will receive the standard care after surgery, while the other group will receive the standard care plus the D-PLEX treatment. The study is designed to be "double-blind," meaning neither the participants nor the researchers will know who is receiving the additional treatment, to ensure unbiased results. The main goal is to observe whether D-PLEX can reduce the rate of infections at the surgical site within 30 days after the operation.

The trial will take place over a period of time, with participants being monitored for any signs of infection or other health issues following their surgery. The safety of D-PLEX will also be closely watched to ensure it does not cause any harmful effects. This study is part of a larger effort to improve recovery and outcomes for patients undergoing abdominal surgery by potentially offering a new way to prevent post-surgical infections.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as undergoing elective colorectal surgery with a large abdominal incision, being stable in terms of blood pressure, heart rate, and temperature, and being of a certain age and gender.

    A negative pregnancy test is required for females of child-bearing potential, and a commitment to using effective contraception during the study is necessary.

  2. Step 2

    Surgery and treatment

    During the surgery, a product called D-PLEX, which contains the active substance doxycycline hyclate, is used. It is a powder that is made into a paste and implanted at the surgical site.

    This treatment is administered alongside the standard care provided for the surgery.

  3. Step 3

    Post-surgery monitoring

    For 30 days following the surgery, the focus is on preventing infections at the incision site. Monitoring involves checking for signs of infection, which can be either superficial or deep.

    The occurrence of any infection is evaluated by an independent committee to ensure unbiased results.

  4. Step 4

    Evaluation of outcomes

    The primary goal is to measure the rate of infection at the incision site within 30 days after surgery. This includes both superficial and deep infections.

    Secondary outcomes include assessing the overall infection rate, any need for additional surgeries, and the presence of antibiotic-resistant bacteria.

  5. Step 5

    Completion of study participation

    Participation in the study concludes after the 30-day post-surgery period, with all data collected being used to evaluate the effectiveness and safety of the treatment.

    The study is expected to continue until the end of 2024, with results contributing to the understanding of infection prevention in abdominal surgeries.

Who can join the trial?

8 criteria

  • Patients must be having a planned surgery on the large intestine, which may involve removing a part of it, with or without creating an opening (stoma). The surgery should include at least one cut on the belly that is longer than 20 centimeters.
  • Patients should be in a stable condition before surgery, meaning their blood pressure, heart rate, and body temperature are within normal ranges.
  • Patients can be male or females who are not pregnant.
  • Females who can have children must have a negative pregnancy test before the surgery and agree to use a reliable method to prevent pregnancy during the study.
  • Patients must be 18 years old or older at the time of joining the study.
  • Patients need to sign a document that shows they understand the study and agree to participate.
  • Patients should be willing and able to follow all the study requirements.
  • Patients should have a life expectancy of at least 60 days after being randomly assigned to a group in the study.

Who cannot join the trial?

10 criteria

  • Patients who have a known allergy to the study medication or any of its components.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of severe allergic reactions, which are strong and potentially life-threatening responses by the body's immune system.
  • Patients with a compromised immune system, meaning their body's defense system is weakened and less able to fight infections.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of drug or alcohol abuse, which means using substances in a way that is harmful to health.
  • Patients with significant liver or kidney disease, which are conditions affecting the organs that help filter and clean the blood.
  • Patients with uncontrolled diabetes, a condition where blood sugar levels are not well managed.
  • Patients who have had a recent heart attack or stroke, which are serious medical events affecting the heart or brain.
  • Patients with any other condition that the study doctors believe would make it unsafe for them to participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

D-PLEX is a medication being tested in this clinical trial to see if it can help prevent infections after abdominal surgery. It is used together with the usual treatments that patients receive after surgery. The goal is to see if adding D-PLEX can reduce the risk of infections at the site of the surgical incision. The trial also aims to ensure that D-PLEX is safe for patients to use alongside their standard care.

What is already known about the treatment

D-PLEX – D-PLEX is administered directly at the surgical site during abdominal surgery to prevent infections in the incision area. It is currently being studied in a Phase III clinical trial to evaluate its effectiveness and safety when used alongside standard care practices. The main therapeutic indication for D-PLEX is the prevention of post-surgical incisional infections. At the molecular level, D-PLEX works by releasing antimicrobial agents locally at the surgical site, which helps to reduce the risk of infection. It is classified pharmacologically as an anti-infective agent.

Investigated diseases

  • Deep Incisional Surgical Site Infection

    This condition occurs when bacteria infect the deeper layers of tissue at the site of a surgical incision. It typically develops within 30 days after surgery and can involve the muscles and tissues surrounding the surgical area. Symptoms may include redness, swelling, and pain at the incision site, along with fever and drainage of pus. The infection can spread to surrounding tissues if not managed properly. It is more common in surgeries involving larger incisions, such as those over 20 cm. The condition requires careful monitoring to prevent further complications.

  • Superficial Incisional Surgical Site Infection

    This type of infection affects only the skin and subcutaneous tissue at the site of a surgical incision. It usually appears within 30 days post-surgery and is characterized by redness, warmth, swelling, and pain around the incision. There may also be drainage of pus or other fluids from the wound. The infection is generally less severe than deep incisional infections but still requires attention to prevent progression. It is more likely to occur in surgeries with longer incisions. Proper wound care and hygiene are essential to manage this condition.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509698-21-00Protocol codeD-PLEX 312Estimated enrolment1 337 patientsSponsorPolypid Ltd.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.