Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT06319235
Eligibility Criteria:
Inclusion Criteria:
* Patients with surgical wound infection and/or dehiscence
* Wound infected by S. aureus and/or P. aeruginosa according to wound swab.
* Wound in the groin or any other skin fold as per Investigator's discretion.
* Signed Informed Consent Form, approved by the ethical committee and competent authority.
* The age between 18 and 75 years.
* Patients able and willing to comply with study procedures.
* There are no contraindications for planned concomitant medication.
* Persisting symptoms of bacterial infection \< 3 weeks since the surgery.
* Women of childbearing potential must take highly effective contraceptive measures since the study start and one month after the treatment administration at a minimum.
Exclusion Criteria:
* History of an organ or bone marrow transplantation.
* Any autoimmune disease.
* Uncompensated diabetes mellitus, confirmed by the concentration of HbA1c \>60 mmol/mol (6%).
* Systematic immunosuppressive therapy.
* Malignancy treatment \<1 year before the Baseline visit.
* COVID-19 infection \<3 months before the Baseline visit, any signs of post-COVID syndrome.
* Pregnancy or planning to become pregnant during the study.
* Breastfeeding.
* Participation in another clinical study.
* Hypersensitivity to the IMP or placebo.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06319235
Study Brief:
Protocol Section:
NCT06319235