Trials / Completed
CompletedNCT04731753
PMCF Study to Examine the Debridement Pad Cutimed DebriClean
Post Market Clinical Follow up Study to Examine Clinical Performance of the Debridement Pad Cutimed DebriClean
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 62 (actual)
- Sponsor
- BSN Medical GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 photo documentation of the wound and evaluation of the wound bed condition and wound size before and after the debridement.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | mechanical debridement | The mechanical debridement is performed using the debridement pad Cutimed DebriClean. After the pad is moistened with wound-cleansing solution, the wound is cleaned using circular movements while applying gentle pressure. |
Timeline
- Start date
- 2021-04-27
- Primary completion
- 2022-05-30
- Completion
- 2022-05-30
- First posted
- 2021-02-01
- Last updated
- 2022-07-20
Locations
3 sites across 2 countries: Germany, United Kingdom
Source: ClinicalTrials.gov record NCT04731753. Inclusion in this directory is not an endorsement.