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The investigation is designed as a prospective, open, non-controlled clinical investigation.
Wounds to be treated under this protocol should be acute non-infected wounds or post surgical infected wounds in hospitalized subjects. One ulcer per subject will be treated for a maximum duration of 3 weeks. All subjects will receive continuous negative pressure treatment with the new NPWT system with a pressure level of -120 mmHg or according to clinicians' instruction based on the indication.
10-15 subjects at two sites will be enrolled provided that they fulfil all the inclusion criteria and none of the exclusion criteria and who have signed and dated a written informed consent.
The subjects will be consecutively allocated to a specific subject identification code. The primary variable wound healing and granulation tissue formation will be assessed by digital planimeter, digital photography and visual estimation.
Subject pain will be measured by using the Visual Analogue Scale, VAS. Subject and investigator convenience will be assessed by convenience surveys. Diagnosis and treatment of wound infections according to clinical routine.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New NPWT system | Device | According clinical routine (Instruction for Use) |
| Measure | Description | Time Frame |
|---|---|---|
| Granulation tissue formation | To assess the wound healing and granulation tissue formation when using the NPWT system | maximum 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Handling of NPWT system | To investigate the pain level at dressing removal To visually check exudate removal To investigate the ease of use for the subject and care giver when using the NPWT system | maximum 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Bischoff, Prof. Dr. med | Ulm University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulm University Hospital | Ulm | Germany |
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