EUCTR2018-003321-29-DE
Active, not recruiting
Phase 1
Clinical relevance of the antimicrobial resistance testing in the treatment of chronic wounds with antiseptics - AntiSeptic
RWTH Aachen University represented by the Rector himself, represented by the Dean of the Medical Faculty0 sites0 target enrollmentJuly 1, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Decubitus, acute or chronic wounds (open wounds existing = 14 days)
- Sponsor
- RWTH Aachen University represented by the Rector himself, represented by the Dean of the Medical Faculty
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Age \= 18 years
- •2\.Decubitus OR secondary healing acute and chronic wounds
- •3\.Positively tested wound swab for bacteria (incl. multi\-resistant bacteria)
- •4\.Patient is capable of understanding the nature, significance and consequence of the clinical trial
- •5\.Given written consent
- •6\.Women of child bearing potential (WOCBP) who apply appropriate methods of contraception throughout the duration of the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 40
Exclusion Criteria
- •1\.Occlusive dressing (e.g. VAC)
- •2\.Pregnant or lactating women
- •3\.Known allergies against investigational products
Outcomes
Primary Outcomes
Not specified
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