PB-TX-01 to treat patients with chronic wounds colonized by Pseudomonas aeruginosa.

INTERVENTION: Product Name: PB‐TX‐01, Product Code:PRD12743384, Pharmaceutical Form: CUTANEOUS POWDER, Other descriptive name: , Strength: , Product Name: Serasept® 2 Antiseptische Lösung, Product Code:PRD694028, Pharmaceutical Form: CUTANEOUS SOLUTION, Other descriptive name: , Strength: CONDITION: Chronic wound colonized by Pseudomonas aeruginosa ; MedDRA version: 21.1Level: PTClassification code: 10059444Term: Wound infection pseudomonas Class: 100000004862 Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: Main Objective: To evaluate (1) the safety and (2) the efficacy of PB‐TX‐01 compared to the comparator Serasept in patients with chronic wounds colonized by P. aeruginosa. This will be measured by (1) the incidence, severity, and causality of adverse events within the clinical trial period of 90 days and (2) the reduction in P. aeruginosa bacterial load after 14 days of topical administration of the IMP. Primary end point(s): Incidence, severity, and causality of treatment‐emergent adverse events (TEAEs) and serious adverse events (SAEs) within 90 days, coded using MedDRA and graded according to CTCAE v6.0 (2025)., Reduction of P. aeruginosa bacterial load after 14 days of treatment relative to baseline. Bacterial load will be measured by the presence of colony forming units (CFUs) in bacterial swabs observed after streak plating and categorized into the values “not existent”, “isolated”, “moderate”, “numerous” or “abundant”. Reduction will be defined as “at least one level less” (e.g., from abundant to numerous). Secondary Objective: To evaluate the difference in the reduction of wound size after 90 days relative to the baseline between test and control group., To evaluate the difference in mean acute pain of wound treatment (measured through pain visual analogue scale) from Day 1 until Day 14 between test and control group., To evaluate the difference in the reduction of clinical signs of infection (measured by the therapeutic index for local infections (TILI)‐score) after 14 days of treatment relative to baseline between test and control group., To evaluate the difference in the improvement in health status (measured by EQ‐5D visual analog scale) on Day 29 relative to baseline between test and control group., To evaluate the difference in the improvement in disease‐specific, health‐related quality of life (as measured by the Wound‐QoL‐17 score) on Day 29 relative to baseline between test and control group. SECONDARY OUTCOME: Secondary end point(s):Eradication of P. aeruginosa as measured by bacterial swab result (=”not existent”) after 14 days of treatment. Secondary end point(s):Improvement in disease‐specific, health‐related quality of life (as measured by the Wound‐QoL‐17 score) on Day 29 relative to baseline. Secondary end point(s):Improvement in health status (measured by EQ‐5D visual analog scale) on Day 29 relative to baseline. Secondary end point(s):Mean acute pain of wound treatment (measured through pain visual analogue scale) from Day 1 until Day 14. Secondary end point(s):Reduction of clinical signs of infection (measured by the therapeutic inde Xfor local infections (TILI)‐score) after 14 days of treatment relative to baseline. Secondary end point(s):Reduction of wound size after 90 days relative to baseline. INCLUSION CRITERIA: Adults aged at least 18 years at the time of written informed consent, Diagnosed with a chronic wound (present for at least 6 weeks prior to Screening) colonized by P. aeruginosa at the beginning of the clinical trial (Screening and Day 1) (polymicrobial infections are allowed as long as P. aeruginosa is present), Available for daily dressing changes during the treatment period., Able to understand and evaluate the informed consent form (ICF) (including the risks and discomfort to which they would agree to be exposed) and to personally sign and date it (for inclusion in the clinical trial, written and signed informed consent must be obtained), If female: using highly effective contraception and agreeing to continue use for the duration of the individual clinical trial period, or evidence of non‐childbearing potential