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Part A The primary objective of Part A will be to verify performance and safety of Mepitel® Ag, a meshed, non- adherent soft silicone wound contact layer containing silver in the treatment of skin grafts in surgical burn patients.
Part B The primary objective of Part B will be to examine the usefulness of Mepilex® Transfer Ag as an adequate option for donor site healing.
This post market clinical follow-up investigation is designed as an open, non-controlled, multi- centre, clinical investigation.
A total of approximately 25 subjects from among 4-6 clinical investigative sites will be evaluated providing they fulfill all the inclusion criteria and none of the exclusion criteria. A signed and dated informed consent/assent will be obtained for all subjects.
Subjects to be included will present with a thermal burn injury that will require skin grafting and result in a donor site. Overall percent Total Body Surface Area (%TBSA) burned will not exceed 30%.
The subjects will be consecutively allocated to a subject code providing they fulfill all inclusion criteria and none of the exclusion criteria and have signed a written consent.
The subjects were participating in the study for 14 days postop.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepitel® Ag | Experimental | A dressing device used for surgical burn wounds with skin graft. |
|
| Mepilex® Transfer Ag | Experimental | Donor site dressing device in the very same patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepitel® Ag | Device | A soft silicone wound contact layer that allows exudates to pass vertically into a secondary absorbent dressing. The product provides fixation and protection of the tissues and has antimicrobial properties. This silicone net dressing will be used to prevent lifting and adherence of skin grafts to the dressings, as well as to prevent pain, and promote healing. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of Participants With Healing | Part A: Adequate take of skin graft (defined as at least 95% adherent and healed as assessed by clinical investigator). | 14 days |
| Part B | Part B: The healing percentage of donor sites (defined as greater than 95% epithelialization, verified by quantitative photographic analysis). | 14 days with 2 visits |
| Measure | Description | Time Frame |
|---|---|---|
| Part A Secondary Outcome. | Satisfactory fixation of the product over the skin graft was assessed by a series of questions regarding the product assessment of product in place at each visit. Ability to pass exudate to the secondary dressing was demonstrated by a series of questions regarding the exudate at each visit as well as the adherence of the dressing at removal which would show the ability of the dressing to pass the exudate to the secondary dressing rather than creating eschar between the wound and the dressing. |
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Part A
Inclusion Criteria
Exclusion Criteria
Part B
Inclusion Criteria
-There must be healthy, intact peri-wound skin surrounding the planned donor site to allow for adequate overlap of study product (5 cm)
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Paul Glat, Professor | Drexel University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Arizona Burn Center | Phoenix | Arizona | 85008 | United States | ||
| The University of South Florida Board of Trustees |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | Mepitel® Ag treatment on graft covered wounds 25 patients. Mepilex® Transfer Ag treatment on donor site 19 patients |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period A (Graft Site) |
|
| |||||||||||||||||||||
| Period B (Donor Site) |
|
ITT population
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants were enrolled into part A where the subjects were treated with Mepitel Ag on a surgical burn wound. Then, eligible subjects from part A, had skin from a "Donor site" to help the burn wound heal. The "Donor site" was also treated and these patients were included i part B. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participants in Part A=25 and Participants in Part B=19. Every patient in Part A was not eligible for Part B. |
| 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 | Part A: Number of Participants With Healing | Part A: Adequate take of skin graft (defined as at least 95% adherent and healed as assessed by clinical investigator). | ITT population. During the surgery, the Phycisian decided that one patient should not receive any skin graft. Therefore there are only 24 patients in Part A and 18 patients in Part B. At Baseline there were 25 ITT patients evaluated for Part A and 19 patients for Part B. | Posted | Count of Participants | Participants | 14 days |
|
|
14 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 | Overall Study | Mepitel Ag treatment and Mepilex Transfer Ag | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| infection | Infections and infestations | Non-systematic Assessment | suspected infection at graft site |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Research Director | Mölnlycke Health Care | +46 31 722 30 00 | info@monlycke.com |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Two Parts (part A and B) with one dressing device for the skin graft placed on a surgical burn wound and another dressing device placed on the donor site.
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|
| Mepilex® Transfer Ag | Device | 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 consists of a Safetac® adhesive layer and compressed polyurethane foam containing silver sulphate and activated carbon. Safetac® is a unique adhesive technology that minimizes pain to patients and trauma to wounds and the surrounding skin. It minimizes risk for maceration by sealing the wound margins; ensuring exudate does not spread to the surrounding skin. |
|
| 14 days with 2 visits |
| Part B Secondary Outcome. | Ability of Mepilex® Transfer Ag to adhere to donor site without slippage. | 14 days with 2 visits |
| Orlando |
| Florida |
| 32886-4687 |
| United States |
| Long Island Plastic Surgical Group | New York | New York | 11530 | United States |
| St. Chrisopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | United States |
|
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | All participants were enrolled into part A where the subjects were treated with Mepitel Ag on a surgical burn wound. Then, eligible subjects from part A, had skin from a "Donor site" to help the burn wound heal. The "Donor site" was also treated and these patients were included i part B. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Part B | Part B: The healing percentage of donor sites (defined as greater than 95% epithelialization, verified by quantitative photographic analysis). | ITT population. During the surgery, the Phycisian decided that one patient should not receive any skin graft. Therefore there are only 24 patients in Part A and 18 patients in Part B. At Baseline there were 25 ITT patients evaluated for Part A and 19 patients for Part B. | Posted | Count of Participants | Participants | 14 days with 2 visits |
|
|
|
| Secondary | Part A Secondary Outcome. | Satisfactory fixation of the product over the skin graft was assessed by a series of questions regarding the product assessment of product in place at each visit. Ability to pass exudate to the secondary dressing was demonstrated by a series of questions regarding the exudate at each visit as well as the adherence of the dressing at removal which would show the ability of the dressing to pass the exudate to the secondary dressing rather than creating eschar between the wound and the dressing. | ITT population | Posted | Count of Participants | Participants | 14 days with 2 visits |
|
|
|
| Secondary | Part B Secondary Outcome. | Ability of Mepilex® Transfer Ag to adhere to donor site without slippage. | ITT population | Posted | Count of Participants | Participants | 14 days with 2 visits |
|
|
|
| 25 |
| 0 |
| 25 |
| 6 |
| 25 |
|
| infection | Infections and infestations | Non-systematic Assessment | suspected infection at donor site |
|
| leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment | leukosytosis potential from allografted area of burn |
|
| hypocalcemia | Blood and lymphatic system disorders | Non-systematic Assessment | hypocalcemia |
|
| hypermagnesemia | Blood and lymphatic system disorders | Non-systematic Assessment | hypermagnesemia |
|
| hyperphosphatemia | Blood and lymphatic system disorders | Non-systematic Assessment | hyperphosphatemia |
|
| hypertension | Blood and lymphatic system disorders | Non-systematic Assessment | hypertension |
|
| muscle spasm | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | muscle spasm |
|
| femoral artery IV site infiltrated | Surgical and medical procedures | Non-systematic Assessment | femoral artery IV site infiltrated |
|
| high blood pressure | Blood and lymphatic system disorders | Non-systematic Assessment | post-op high blood pressure |
|
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| Day 14: Graft take/Donor site healed ≥95%=No |
|
|
| Day 14: Donor site healed ≥95%=Yes |
|
|
| Title | Measurements |
|---|---|
|
| Day 7: Graft lift off with removal of product: No |
|
| Day 7: Graft lift off with removal of product: Yes |
|
| Day 14: Was there any adherence to the graft: No |
|
| Day 14: Was there any adherence to the graft: Yes |
|
|
| Day 7: Was removal assessment performed: Yes |
|
|
| Day 7: Did product stick to donor site: No |
|
|
| Day 7: Did product stick to donor site: Yes |
|
|
| Day 14: Was adherence of product assessed: Yes |
|
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| Day 14: Was removal assessment performed: Yes |
|
|
| Day 14: Did product stick to donor site: No |
|
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