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This is a prospective, open, non-controlled clinical investigation to evaluate the performance and safety of using Mepilex Transfer Ag on a malignant wound. Approximately ten to fifteen (10-15) subjects from one to three centers in Europe, presenting with a malignant (fungating) wound will be enrolled into the study. Eligible subjects will have one malignant (fungating) wound selected as a "study site". Subjects will be followed for a one-week observation period with their existing product followed by a 4-week investigation period using Mepilex Transfer Ag.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepilex Transfer Ag | Experimental | Non controlled investigation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepilex Transfer Ag | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Infection in the Wound (Signs of Clinical Infection) | Weekly Visual inspection of the wounds by the investigators. | weekly, for 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles University School of Medicine | Prague | Prague | Czechia | |||
| The General University Hospital in Prague |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mepilex Transfer Ag | Non controlled investigation Mepilex Transfer Ag |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Prague |
| Prague |
| Czechia |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mepilex Transfer Ag | Non controlled investigation Mepilex Transfer Ag |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Infections in the wound at baseline | inclusion criteria is exuding malignant wound in need for antimicrobial treatment | Number | participants |
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| Pain during dressing changes | Number | participants |
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| Exudate handling | chronic wound exudate handling | Number | participants |
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| Presence of malodour | Number | participants |
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| Presence of bleeding from tumor | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Infection in the Wound (Signs of Clinical Infection) | Weekly Visual inspection of the wounds by the investigators. | ITT population | Posted | Number | participants | weekly, for 5 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mepilex Transfer Ag | Non controlled investigation Mepilex Transfer Ag | 0 | 14 | 0 | 14 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Petr Arenberger | Faculty Hospital Kralovske Czech Republic | +420 267 16 11 11 | avemedica@email.cz |