Status:
COMPLETED
PMCF Study to Examine the Debridement Pad Cutimed DebriClean
Lead Sponsor:
BSN Medical GmbH
Conditions:
Wound
Eligibility:
All Genders
18+ years
Brief Summary
Documentation of the performance and safety of the debridement pad Cutimed DebriClean in daily clinical practice
Detailed Description
60 subjects with superficial wounds in need of debridement will undergo mechanical debridement with the study product. Per subject, one application of the study product will be documented including p...
Eligibility Criteria
Inclusion
- Male or female subjects aged 18 years or older with full legal competence
- Signed informed consent
- Subjects with wounds in need of debridement, especially diabetic ulcers, venous and arterial ulcers, pressure sores, postoperative wounds and wounds healing by secondary intention, superficial burns
- Superficial wound
- Minimum 30 % of the wound is covered by debris, necrosis or slough
- Wound size \> 4 cm²
Exclusion
- Subjects not willing to participate or to attend the scheduled study visit
- Known sensitivity or allergy to the product components
- Severe pain or hyperaesthesia in the wound area
- Patients who are pregnant or lactating
- Drug abuse or alcohol abuse
- Patients who participate in any other clinical study investigating drugs or medical devices
Key Trial Info
Start Date :
April 27 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2022
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04731753
Start Date
April 27 2021
End Date
May 30 2022
Last Update
July 20 2022
Active Locations (3)
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1
Praxis am Stadtpark
Ahlen, North Rhine-Westphalia, Germany, 59227
2
Universitäres Herz- und Gefäßzentrum, Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20251
3
Pinderfields Hospital
Wakefield, West Yorkshire, United Kingdom, WF1 3DG