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The investigator will identify the test donor site and test location will be considered on the upper anterior thighs as being the most suitable if available. Circumferential donors will be considered acceptable as well.
Treatment will be initiated in the operation room following debridement and split thickness grafting of wounds. Donors will be harvested at 0.010 - 0.012 in. thickness. Treatment and dressing of test donor site will include hemostasis post harvesting with epinephrine-soaked lap sponges. Once adequate hemostasis is achieved, a Mepilex Transfer Ag dressing will be applied directly to study site. Secondary dressing will include covering with ace wrap.
Healing should be asses after 10-14 days.
A prospective, open, non-controlled clinical investigation to evaluate the adequacy of donor site healing when using a new donor site dressing, Mepilex Transfer Ag approximately 20 subjects from 2 centres in the US, presenting with the need for surgical intervention and grafting for burn injury will be enrolled. Eligible subjects will have a selected donor site designated as a "study site".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepilex Transfer Ag | Experimental | Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepilex Transfer Ag | Device | Silver dressing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Had > 95 % Epithelialization at Day 10 | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at Dressing Changes | The Medain and Full Range values are presented for all pain scores collected over multiple dressing changes, per participant, over the course of 28 Days. Adult ( 13 years and older) patient informed about his/her pain from No pain (0) to Most intense pain (100) imaginable, by using the Visual Analogue Scale ( VAS), Children were using the WONG baker faces, they could chose between, no hurt, hurts Little bit, hurts Little more, hurts even more hurts whole lot hurts worst. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Gibran, MD | UW Medicine Regional Burn Center Seattle, WA 98104 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LongIsland Plastic Surgical Group, PC | Garden City | New York | 11530 | United States | ||
| Harborview Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mepilex Transfer Ag | Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties. Mepilex Transfer Ag: Silver dressing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mepilex Transfer Ag | Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties. Mepilex Transfer Ag: Silver dressing |
| 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 |
| 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 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Pain at Dressing Changes | The Medain and Full Range values are presented for all pain scores collected over multiple dressing changes, per participant, over the course of 28 Days. Adult ( 13 years and older) patient informed about his/her pain from No pain (0) to Most intense pain (100) imaginable, by using the Visual Analogue Scale ( VAS), Children were using the WONG baker faces, they could chose between, no hurt, hurts Little bit, hurts Little more, hurts even more hurts whole lot hurts worst. | Posted | Median | Full Range | units on a scale VAS 0-100 | 28 days |
|
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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 | Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties. Mepilex Transfer Ag: Silver dressing |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening disruption of wound healing | Skin and subcutaneous tissue disorders | Worsening disruption of wound healing |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection to donor site | Skin and subcutaneous tissue disorders | Infection to donor site |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Nicole Gibran | Harborview Medical Center / Seattle, Washington | 206-744-3140 | nicoleg@uw.edu |
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| 28 days |
| Seattle |
| Washington |
| 98104 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
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| Primary | Percentage of Participants Who Had > 95 % Epithelialization at Day 10 | Posted | Number | percentage of participants | 10 days |
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| 1 |
| 8 |
| 1 |
| 8 |
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