DRKS00014861
Active, not recruiting
Not Applicable
Post-market clinical follow-up study to evaluate the performance and safety of Suprasorb® A + Ag wound dressing and rope in the treatment of chronic wounds - Suprasorb® A + Ag
ohmann & Rauscher GmbH & Co. KG0 sites9 target enrollmentJune 11, 2018
ConditionsPresence of a chronic wound according to the instruction for use:- venous leg ulcer or- arterial ulcer (ABPI > 0,5) or- arterial and venous leg ulcer (ABPI > 0,5) or- pressure ulcer (category II – IV) or- diabetic foot ulcer or- post-operative wound healing disturbance or- donor sites or mesh graphsL89.1L89.2L89.3Stage II decubitus ulcerStage III decubitus ulcerStage IV decubitus ulcer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Presence of a chronic wound according to the instruction for use:- venous leg ulcer or- arterial ulcer (ABPI > 0,5) or- arterial and venous leg ulcer (ABPI > 0,5) or- pressure ulcer (category II – IV) or- diabetic foot ulcer or- post-operative wound healing disturbance or- donor sites or mesh graphs
- Sponsor
- ohmann & Rauscher GmbH & Co. KG
- Enrollment
- 9
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \= 18 years
- •Patient is legally capable
- •Chronic wounds not existing for more than 36 months (ICW clas\-sification)
- •Presence of a chronic wound according to the instruction for use:
- •\- venous leg ulcer or
- •\- arterial ulcer (ABPI \> 0,5\) or
- •\- arterial and venous leg ulcer (ABPI \> 0,5\) or
- •\- pressure ulcer (category II – IV) or
- •\- diabetic foot ulcer or
- •\- post\-operative wound healing disturbance or
Exclusion Criteria
- •Treatment with Suprasorb® A \+ Ag silver calcium alginate wound dressing and rope or a similar silver containing alginate dressing during the last 4 weeks
- •Known sensitivity to Suprasorb® A \+ Ag Antimicrobial Calcium Alginate Wound Dressing and Rope
- •or any of their components
- •Malignant wounds (tumor related wounds)
- •Critical limb ischemia
- •Planned amputation in the next 2 months
- •A planned surgical operation in the region of the study wound in the next 8 weeks following inclusion
- •Patient is not compliant regarding treatment of the underlying disease (e.g. compression)
- •Dry wound
- •Pregnancy or breast feeding
Outcomes
Primary Outcomes
Not specified
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