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| Name | Class |
|---|---|
| WPM - Wund Pflege Management Ges.m.b.H | UNKNOWN |
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In the course of this clinical trial, it was shown that the use of Granudacyn/VERIFORTE med wound irrigation solution in the course of adjuvant therapy supports wound healing through mechanical irrigation and moistening of the wound. No risks have been reported. The benefits of using Granudacyn/VERIFORTE med wound irrigation solution therefore outweigh the potential risks.
Aim of this clinical trial was to collect clinical data on the performance and safety of the use of Granudacyn/VERIFORTE med as a wound irrigation solution, for cleansing and irrigation of acute, chronic or contaminated wounds.
The evaluation of the safety of the use of Granudacyn/VERIFORTE med wound irrigation solution within the scope of use was based on the frequency of adverse events (AEs) and, in particular, treatment-emergent adverse events (ADEs).
Study Design:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Granudacyn/Veriforte | Device | Wound irrigation solution for all kinds of wounds (Acute, chronic or contaminated wounds). |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of safety: • AES: 0,00%, 95% CI: (0,00% - 4,16%) • ADEs: 0,00%, 95% CI: (0,00% - 4,16%) | Evaluation of the safety of the use of Granudacyn/VERIFORTE med wound irrigation solution within the scope of use, based on the frequency of adverse events (AEs) and, in particular, treatment-emergent adverse events (ADEs). | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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One treatment group (single-arm): All subjects participating in the study will be treated with Granudacyn/VERIFORTE med wound irrigation solution. People with a completed treatment of an acute or chronic wound participated in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PGF Industry Solutions GmbH | Salzburg | Austria |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D002056 | Burns |
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