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

• 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; L89.1; L89.2; L89.3; Stage II decubitus ulcer; Stage III decubitus ulcer; Stage IV decubitus ulcer

• Registration Number: DRKS00014861
• Lead Sponsor: ohmann & Rauscher GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-11
• Study Completion: 2019-08-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 9

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
- donor sites or mesh graphs
• Infected wound or wound with risk of infection (W.A.R. Score = 3*)
• Heavily exuding wound
• Wound area between 4 and 100 cm2
•It must be possible to display the entire wound area on one photo from a distance of 25-30 cm
• Patient has signed written Informed Consent

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
• Reliable severe malnutrition
• Patient is analphabet
• Participation in a therapeutic trial in the last 3 months and during participation in this study

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The wound shift after application of Suprasorb® A + Ag is used as parameter for performance assessment. For an objective assessment of the wound shift, reduction of fibrin slough is technically measured by evaluation of the photographic wound documentation with the Wound Healing Analysing Tool (W.H.A.T.). The wound is assessed before<br>the first time of application and after 4 weeks of treatment with Suprasorb® A + Ag. Success of treatment is defined as a reduction of fibrin slough of at least 50% after 4 weeks, measured by W.H.A.T.<br>Additionally the wound shift is clinically assessed by the investigator at the same time schedule.

Secondary Outcome Measures

Name	Time	Method
Frequency and severity of device related adverse events and incidents are evaluated.