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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach	Katowice	Poland
Miejskie Centrum Medyczne Im. Dr. Karola Jonschera W Lodzi	Lodz	Poland

Other Sites

Site Name	City	Country
Kistarcsai Flor Ferenc Korhaz	Kistarcsa	Hungary
Portiuncula University Hospital	Galway	Ireland
Spitalul Clinic Judetean De Urgenta Craiova	Craiova	Romania
Bekes Varmegyei Koezponti Korhaz	Gyula	Hungary
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Bajai Szent Rokus Korhaz	Baja	Hungary
Our Lady Of Lourdes Hospital	Drogheda	Ireland
Wojewodzki Szpital Specjalistyczny We Wroclawiu	Wroclaw	Poland
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz	Szekesfehervar	Hungary
Spitalul Clinic Judetean De Urgenta Pius Brinzeu	Timisoara	Romania
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Saarland University Hospital	Homburg	Germany
Semmelweis University	Budapest	Hungary
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Di Pisa	Pisa	Italy
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz	Nyiregyhaza	Hungary
Markhot Ferenc Oktatokorhaz Es Rendelointezet	Eger	Hungary
Centro Hospitalar Do Baixo Vouga E.P.E. (CHBV E.P.E.)	Aveiro	Portugal
Unidade Local De Saude Da Guarda E.P.E.	Guarda	Portugal
Spitalul Clinic Judetean Mures	Targu Mures	Romania
University Of Szeged	Szeged	Hungary
Connolly Hospital	Dublin	Ireland
Budapesti Uzsoki Utcai Korhaz	Budapest	Hungary
Ssfpswua Swk Cjoxuvyzub	Brasov	Romania
Bldjgobfzdl Vpdlodrdi Onhcvbrkmdrz	Kecskemet	Hungary
Snlkyfxhpap Pwapodtno Zjekww Zjjpbnpo Otdmuf Zhyijjtfts W Oijgjul Mekzwpkzmaya	Ostrow Mazowiecka	Poland
Uoxeeboczfddelulrnnjg Mrmrokge Azh	Munster	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	27.04.2021
Hungary	Not recruiting	27.04.2021
Ireland	Not recruiting	27.04.2021
Italy	Not recruiting	27.04.2021
Poland	Not recruiting	27.04.2021
Portugal	Not recruiting	27.04.2021
Romania	Not recruiting	27.04.2021

Trial locations

Investigated drugs:

Doxycycline Hyclate

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.

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 ID:

2023-509698-21-00

Protocol code:

D-PLEX 312

NCT ID:

NCT04411199

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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