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The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of Exufiber when used as intended in Stage II-IV pressure ulcers (PU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fast Gelling Dressing | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fast Gelling Dressing (Exufiber) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks) | the subjects will be measured by the following variables; maceration, | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance | Pain during product removal at week 6, measured by Visual Analog scale.This will be measured by the following variables; visual analog scale, 0=no pain, 100= worst pain, scale from 0-100 mm | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hilde Beele, prof. dr | University Hospital Gent, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatologie Campus Kennedylaan | Kortrijk | Kortrijk | 8500 | Belgium | ||
| Dep. of Plastic Surgery UZ Bruzzel |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fast Gelling Dressing | Fast Gelling Dressing (Exufiber) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Brussels |
| 1000 |
| Belgium |
| University Hospital Gent, Belgium | Ghent | 9000 Gent | Belgium |
| Töölö Hospital | Helsinki | 00260 | Finland |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fast Gelling Dressing | Fast Gelling Dressing (Exufiber) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | 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 | Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks) | the subjects will be measured by the following variables; maceration, | Posted | Number | participants | 6 weeks |
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| Secondary | Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance | Pain during product removal at week 6, measured by Visual Analog scale.This will be measured by the following variables; visual analog scale, 0=no pain, 100= worst pain, scale from 0-100 mm | Posted | Median | Inter-Quartile Range | units on a scale | 6 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 | Fast Gelling Dressing | Fast Gelling Dressing (Exufiber) | 1 | 21 | 1 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and vomiting | General disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Periwound redness | Skin and subcutaneous tissue disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hilde Beele | Universitair Ziekenhuis Gent | 09/332 22 87 | Hilde.Beele@uzgent.be |
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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