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Documentation of the performance and safety of the debridement pad Cutimed DebriClean in daily clinical practice
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group treated with study product | Subjects will undergo one mechanical debridement procedure with Cutimed DebriClean |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mechanical debridement | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of wound bed condition from baseline to assessment immediately after the mechanical debridement (within one study visit) | Percentage of wound coverage with debris/necrosis/slough Wound edge cleaned smooth Surrounding skin cleaned e.g. from skin flakes | assessed immediately before and immediately after the mechanical debridement (within one study visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Wound size after and before wound debridement | Wound length and wound width are measured using a wound ruler. Wound size is calculated using the formula A = length x width x π/4. | assessed immediately before and immediately after the mechanical debridement (within one study visit) |
| Time needed for the debridement procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with superficial wounds in need of debridement, for example diabetic ulcers, venous and arterial ulcers, pressure sores, postoperative wounds and wounds healing by secondary intention, superficial burns, the absorption of exudate, slough and dry skin flakes.
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| Name | Affiliation | Role |
|---|---|---|
| Leanne Atkin, Dr. | The University of Huddersfield | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis am Stadtpark | Ahlen | North Rhine-Westphalia | 59227 | Germany | ||
| Universitäres Herz- und Gefäßzentrum, Universitätsklinikum Hamburg-Eppendorf |
No IPD will be shared. Data are needed for post market clinical follow up.
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Time from start to completion of the debridement procedure in minutes |
| Time is measured during the debridement procedure |
| Debris/necrosis/slough absorbed by test product | assessed by the investigator (five categories) | assessed immediately after the mechanical debridement |
| Structural integrity of the test product | assessed by the investigator (e.g. change in shape, loosening of fibers, …) | assessed immediately after the mechanical debridement |
| Pain during the debridement procedure | Patient reported pain assessed using a visual analogue scale. If applicable, duration of pain is documented. | assessed immediately after the debridement procedure |
| Adverse device effects | Discomfort, pressure, burning sensation, bleeding, and irritation of the periwound skin during or after the mechanical debridement, other adverse device effects swelling; redness | assessed immediately after the debridement procedure |
| Hamburg |
| 20251 |
| Germany |
| Pinderfields Hospital | Wakefield | West Yorkshire | WF1 3DG | United Kingdom |