Bacterial infection with Staphylococcus aureus and/or Pseudomonas aeruginosa in the surgical wound.
Conditions
Interventions
Product Name: DUOFAG(R)
Product Code: DUOFAG(R)
Pharmaceutical Form: Cutaneous liquid
Pharmaceutical form of the placebo: Cutaneous spray, emulsion
Route of administration of the placebo: Topical
Sponsors
MB PHARMA s. r. o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with surgical wound infection and/or dehiscence 2. Wound infected by S. aureus and/or P. aeruginosa according to wound swab. 3. Wound in the groin or any other skin fold as per Investigator’s discretion. 4. Signed Informed Consent Form, approved by the EC and CA 5. The age between 18 and 75 years. 6. Patients able and willing to comply with study procedures. 7. There are no contraindications for planned concomitant medication. 8. Persisting symptoms of bacterial infection =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. History of an organ or bone marrow transplantation. 2. Any autoimmune disease. 3. Uncompensated diabetes mellitus, confirmed by the concentration of HbA1c >60 mmol/mol (6%). 4. Systematic immunosuppressive therapy. 5. Malignancy treatment <1 year before the Baseline visit. 6. COVID-19 infection <3 months before the Baseline visit, any signs of post-COVID syndrome. 7. Pregnancy or planning to become pregnant during the study. 8. Breastfeeding. 9. Participation in another clinical study. 10. Hypersensitivity to the IMP or placebo.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate the safety of the product and the clinical and microbiological change within 10 weeks after the start of treatment or until healing. ;Secondary Objective: Not Applicable;Primary end point(s): Time to commencement of healing.;Timepoint(s) of evaluation of this end point: Within 10 weeks after treatment start at maximum. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The frequency of the following symptoms following the IMP application will be evaluated: • local reactions (local rash onset, local sensations, worsening of local inflammatory signs, discharge) • systemic reactions (vital signs reactions, fever, rash, arthralgia, gastrointestinal symptoms) Microbiological endpoints: Change of the microbiological profile of the wound assessed by swab (maximum 8 assessment points during the treatment period). Clinical efficacy endpoints: • mLUMT total score change since Baseline • Time since the start of the study treatment until the bacterial infection eradication – i. e. the swab sample is negative on S. aureus and/or P. aeruginosa • Time since the start of the study treatment until the granulation process in the wound has started, as indicated by the score = 2 in all 3 items A8 – A10 of the mLUMT scale. • Time since the start of the study treatment until the wound is closed as assessed by Investigator. ;Timepoint(s) of evaluation of this end point: Secondary endpoints will be evaluated in 10 weeks after treatment start at maximum. | — |
Countries
Czech Republic
Contacts
Public ContactMgr. Dana Štveráková, Ph.D.
MB PHARMA s. r. o.
Outcome results
None listed