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Study on the Safety and Effectiveness of Sodium Chloride and Bacteriophage for Treating Surgical Wound Infections in Patients

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on treating infections in surgical wounds, specifically those caused by the bacteria Staphylococcus aureus and Pseudomonas aeruginosa. The study will use a treatment called DUOFAG®, which is being tested for its safety and effectiveness. The trial will also involve a comparison with a placebo. The main goal is to see if DUOFAG® can safely help heal these infections and improve the condition of the wounds.

Participants in the study will receive the treatment through a method called topical application, which means it is applied directly to the skin. The study will last up to 10 weeks, during which time the healing process of the wound will be closely monitored. Researchers will look for any changes in the wound's condition and check if the infection is cleared. The study will also track any reactions to the treatment, both at the site of application and throughout the body.

The trial aims to provide valuable information on how well DUOFAG® works in treating surgical wound infections and whether it is safe for patients. By the end of the study, researchers hope to determine if this treatment can be a reliable option for managing infections caused by Staphylococcus aureus and Pseudomonas aeruginosa in surgical wounds.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the clinical trial, you will be required to sign an Informed Consent Form. This form confirms your understanding of the trial and your agreement to participate.
You must meet specific criteria, such as having a surgical wound infection caused by S. aureus or P. aeruginosa, and be between the ages of 18 and 75.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your surgical wound. This includes a swab test to confirm the presence of S. aureus or P. aeruginosa.
Your medical history and current health status will be reviewed to ensure there are no contraindications for the trial.
Step 3
Treatment administration
You will receive the trial medication, DUOFAG®, which is applied topically to the wound. The frequency and dosage will be determined by the study protocol.
The treatment will continue for up to 10 weeks or until the wound heals, whichever comes first.
Step 4
Regular monitoring
Throughout the trial, your wound will be regularly monitored for signs of healing and any reactions to the treatment.
You will undergo up to 8 swab assessments to track changes in the microbiological profile of the wound.
Step 5
Safety and efficacy evaluation
The primary goal is to assess the safety of the treatment and its effectiveness in eradicating the bacterial infection.
Both local and systemic reactions will be recorded, including any changes in vital signs or symptoms such as fever or rash.
Step 6
Completion of the trial
At the end of the trial, a final assessment will be conducted to evaluate the overall healing of the wound.
You will be informed of the results and any further steps if necessary.

Who can join the trial?

9 criteria

Patients with a **surgical wound infection** or **dehiscence** (which means the wound has opened up).
The wound must be infected by **S. aureus** and/or **P. aeruginosa** as confirmed by a wound swab test.
The wound is located in the **groin** or any other skin fold, as decided by the study doctor.
Must have signed an **Informed Consent Form** that has been approved by the relevant authorities.
Age must be between **18 and 75 years**.
Must be able and willing to follow the study procedures.
There should be no reasons to avoid the planned additional medications.
Symptoms of bacterial infection must have been present for **less than 3 weeks** since the surgery.
Women who can have children must use **highly effective birth control** from the start of the study and for at least one month after the treatment.

Who cannot join the trial?

3 criteria

Patients with a **surgical wound infection** caused by **S. aureus** or **P. aeruginosa** bacteria cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

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Verified sites

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Fakultni Nemocnice U Sv Anny V Brne
Brno-Stred, Czechia

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Investigated drugs

DUOFAG® is a medication being tested in this clinical trial to see if it can help treat bacterial infections in patients with surgical wounds. The trial aims to find out if DUOFAG® is safe to use and if it can effectively reduce the bacteria causing the infection, helping the wound to heal. The study will monitor patients for changes in their condition over a period of 10 weeks to see how well the medication works and if there are any side effects.

Sodium Chloride

What is already known about the treatment

DUOFAG® – DUOFAG® is administered as a topical treatment, applied directly to surgical wounds. It is currently being studied in a Phase I/IIa clinical trial to assess its safety and effectiveness in treating bacterial infections in surgical wounds, specifically those caused by Staphylococcus aureus and Pseudomonas aeruginosa. The main therapeutic use of DUOFAG® is to help heal surgical wound infections by targeting and reducing harmful bacteria. At the molecular level, it works by disrupting the bacteria's ability to grow and multiply, thereby aiding in the healing process. DUOFAG® is classified pharmacologically as an antibacterial agent.

Investigated diseases

Surgical wound infection – This condition occurs when bacteria, such as Staphylococcus aureus or Pseudomonas aeruginosa, colonize a surgical wound. The infection can lead to inflammation, redness, and discharge from the wound site. As the infection progresses, it may cause increased pain, swelling, and delayed healing. The presence of bacteria can hinder the natural granulation process, which is essential for wound closure. Over time, if not managed, the infection can spread to surrounding tissues. The condition requires careful monitoring to ensure the wound begins to heal properly.