Clinical Relevance of the Antimicrobial Resistance Testing in the Treatment of Chronic Wounds With Antiseptics

• Status: Not yet recruiting
• Trial end date: 2021-05-22
• Target enrollment: 0
• Participant gender: All

Summary

The study objective is to improve the current and local standard antiseptic treatment by adjusting the antiseptic agent to the antimicrobial resistance testing result, accordingly. Currently, resistance testing will only be performed for the treatment with antibiotics.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RWTH Aachen University
• Treatments: Anti-Bacterial Agents; Anti-Infective Agents; Anti-Infective Agents, Local; Octenidine

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

Exclusion Criteria:

1. Occlusive dressing (e.g. VAC) or Negative Pressure Wound Therapy (NPWT)

2. Pregnant or lactating women

3. Known allergies against investigational products