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The purpose of this study is to evaluate the change in signs of inflammation/local infection when Mepilex Border Ag is used in normal clinical practice when used on chronic ulcers (venous leg, diabetic foot and pressure ulcers) and partial thickness burns in need* of topical antimicrobial treatment according to the physician.
The investigation is designed as an open, non-controlled, post-marketing clinical follow-up. Subjects with chronic ulcers or partial thickness burns (including donor sites) at 2 sites will be included. Each subject with a chronic ulcer will be seen once a week for a maximum of 4 weeks or until desired treatment effect is obtained, whichever occurs earlier. Each subject with a partial thickness burn/donor site will be followed once a week for a maximum of 3 weeks or until desired treatment effect is obtained, whichever occurs earlier. All dressing changes will be done according to clinical routine practices and will follow IFU (instruction for use)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepilex Border Ag | Other | Non comparative study with one active arm - Mepilex Border Ag |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepilex Border Ag | Device | Mepilex Border Ag may be left in place for up to seven days, depending on the condition. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound Are at Baseline | Baseline | |
| Wound Area at Visit 2 | At each visit the wound length and width is measured and calculated in cm2. | After one week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Latenser, MD | UI burn Treatment Center,200 Hawkings Dr 8JCP Iowa City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for advanced wound care | Momtgomery | Alabama | 36111 | United States | ||
| Burn treatment center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mepilex Border Ag | Non comparative study with one active arm - Mepilex Border Ag Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Iowa City |
| Iowa |
| 52242 |
| United States |
| Center for Curative & Palliative Care, Calvary Hospital | The Bronx | New York | 10461 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mepilex Border Ag | Non comparative study with one active arm - Mepilex Border Ag Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Wound Are at Baseline | Not Posted | Baseline | |||||||||||||||||||||||||||||||||
| Primary | Wound Area at Visit 2 | At each visit the wound length and width is measured and calculated in cm2. | Posted | Mean | Standard Deviation | cm2 | After one week |
|
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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 Border Ag | Non comparative study with one active arm - Mepilex Border Ag Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition. | 0 | 27 | 0 | 27 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Viktoria Ahlenius Körner | Molnlycke Health Care | 0046 31 7223000 | viktoria.ahleniuskorner@molnlycke.com |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D002056 | Burns |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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