Complicated skin wounds (wounds healing per secundam via granulation tissue) - either as a complication of healing of acute wounds (infected surgical or traumatic wounds) or chronic wounds, in both cases infected with S. aureus and/or P. aeruginosa.
Conditions
Brief summary
Safety: frequency of all serious (local and systemic) adverse reactions and events (see description in the relevant chapter) suspected or confirmed to be related to IMP administration during the IMP administration phase (0-14 days), Efficiency (1): presence of S. aureus and/or P. aeruginosa colonies on wound swabs over the period of IMP application, Efficiency (2): number of S. aureus and/or P. aeruginosa colonies on wound swabs over the period of IMP application
Detailed description
Occurrence and frequency of all (local and systemic) adverse reactions during the treatment and follow-up phase with a suspected or confirmed relatedness to IMP administration, Change in mLUMT score during the treatment and follow-up phase, Time from the start of IMP administration to the point of bacterial infection eradication - negative swab for S. aureus and/or P. aeruginosa, Time from the start of IMP administration until complete wound healing (if this occurs during treatment or follow-up phase), Evaluation of possible differences in efficacy in inpatient and outpatient settings
Interventions
Sponsors
MB PHARMA s.r.o.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: frequency of all serious (local and systemic) adverse reactions and events (see description in the relevant chapter) suspected or confirmed to be related to IMP administration during the IMP administration phase (0-14 days), Efficiency (1): presence of S. aureus and/or P. aeruginosa colonies on wound swabs over the period of IMP application, Efficiency (2): number of S. aureus and/or P. aeruginosa colonies on wound swabs over the period of IMP application | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence and frequency of all (local and systemic) adverse reactions during the treatment and follow-up phase with a suspected or confirmed relatedness to IMP administration, Change in mLUMT score during the treatment and follow-up phase, Time from the start of IMP administration to the point of bacterial infection eradication - negative swab for S. aureus and/or P. aeruginosa, Time from the start of IMP administration until complete wound healing (if this occurs during treatment or follow-up phase), Evaluation of possible differences in efficacy in inpatient and outpatient settings | — |
Outcome results
None listed