Burn Injury, Skin Graft
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMepitel® Ag
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.
DEVICEMepilex® 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 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.
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Months to 65 Years
Healthy volunteers
No
Inclusion criteria
Part A Inclusion Criteria * Subjects with burn injury resulting in up to 30% TBSA * Full thickness area of burn should not be more than 20% * Area in need of skin grafting can be 1-15% TBSA * Study site area must have healthy, intact peri-wound skin surrounding it to allow for adequate overlap of study product * Thermal injuries only * Subjects age 18 months to \< 65 years. * Signed informed consent * Subjects who are younger than the legal consenting age must in addition to their own assent form have a signature from a legally authorized representative.
Exclusion criteria
* Greater than 30% TBSA * Full thickness areas greater than 20% TBSA * Full thickness area to be grafted less than 1% * Presence of respiratory involvement * Subjects on mechanical ventilation * Subjects with infected burn wounds * Subjects with organ failure * Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe aeaemia) judged by the investigator to be a potential interference in the treatment * Subjects treated with systemic glucocorticosteroids, except patients taking occasional doses or doses less than 10mg prednisolone/day or equivalent * Known allergy/hypersensitivity to any of the components of the investigation products. * Subjects with physical and/or mental conditions that are not expected to comply with the investigation, including patients totally confined to bed * Participation in other clinical investigation(s) within 1 month prior to start of the investigation * Previous randomized to this investigation 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Number of Participants With Healing | 14 days | Part A: Adequate take of skin graft (defined as at least 95% adherent and healed as assessed by clinical investigator). |
| Part B | 14 days with 2 visits | Part B: The healing percentage of donor sites (defined as greater than 95% epithelialization, verified by quantitative photographic analysis). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A Secondary Outcome. | 14 days with 2 visits | 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. |
| Part B Secondary Outcome. | 14 days with 2 visits | Ability of Mepilex® Transfer Ag to adhere to donor site without slippage. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Period A (Graft Site) | Physician decided not to graft at OR | 1 |
| Period A (Graft Site) | Withdrawal by Subject | 1 |
| Period B (Donor Site) | 7 subjects healed at or before Day 14 | 7 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous Part A | 28.6 years |
| Age, Continuous Part B | 26.9 years |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Part A Female | 6 Participants |
| Sex: Female, Male Part A Male | 19 Participants |
| Sex: Female, Male Part B Female | 4 Participants |
| Sex: Female, Male Part B Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 6 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
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).
Time frame: 14 days
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Mepitel Ag | Part A: Number of Participants With Healing | Day 7: Graft take healed ≥95%=No | 3 Participants |
| Part A: Mepitel Ag | Part A: Number of Participants With Healing | Day 7: Graft take healed ≥95%=Yes | 21 Participants |
| Part A: Mepitel Ag | Part A: Number of Participants With Healing | Day 14: Graft take healed ≥95%=No | 2 Participants |
| Part A: Mepitel Ag | Part A: Number of Participants With Healing | Day 14: Graft take healed ≥95%=Yes | 22 Participants |
Primary
Part B
Part B: The healing percentage of donor sites (defined as greater than 95% epithelialization, verified by quantitative photographic analysis).
Time frame: 14 days with 2 visits
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Mepitel Ag | Part B | Day 7: Donor site healed ≥95%=No | 15 Participants |
| Part A: Mepitel Ag | Part B | Day 14: Graft take/Donor site healed ≥95%=No | 2 Participants |
| Part A: Mepitel Ag | Part B | Day 14: Donor site healed ≥95%=Yes | 4 Participants |
| Part A: Mepitel Ag | Part B | Day 7: Donor site healed ≥95%=Yes | 3 Participants |
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.
Time frame: 14 days with 2 visits
Population: ITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Mepitel Ag | Part A Secondary Outcome. | Day 7: Was a product removal performed: Yes | 24 Participants |
| Part A: Mepitel Ag | Part A Secondary Outcome. | Day 7: Graft lift off with removal of product: No | 22 Participants |
| Part A: Mepitel Ag | Part A Secondary Outcome. | Day 7: Graft lift off with removal of product: Yes | 2 Participants |
| Part A: Mepitel Ag | Part A Secondary Outcome. | Day 14: Was there any adherence to the graft: Yes | 3 Participants |
| Part A: Mepitel Ag | Part A Secondary Outcome. | Day 7: Was there any adherence to the graft: No | 20 Participants |
| Part A: Mepitel Ag | Part A Secondary Outcome. | Day 7: Was there any adherence to the graft: Yes | 4 Participants |
| Part A: Mepitel Ag | Part A Secondary Outcome. | Day 14: Was there any adherence to the graft: No | 16 Participants |
Secondary
Part B Secondary Outcome.
Ability of Mepilex® Transfer Ag to adhere to donor site without slippage.
Time frame: 14 days with 2 visits
Population: ITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Mepitel Ag | Part B Secondary Outcome. | Day 7: Was adherence of product assessed: No | 2 Participants |
| Part A: Mepitel Ag | Part B Secondary Outcome. | Day 7: Was adherence of product assessed: Yes | 16 Participants |
| Part A: Mepitel Ag | Part B Secondary Outcome. | Day 7: Was removal assessment performed: Yes | 3 Participants |
| Part A: Mepitel Ag | Part B Secondary Outcome. | Day 7: Did product stick to donor site: No | 2 Participants |
| Part A: Mepitel Ag | Part B Secondary Outcome. | Day 7: Did product stick to donor site: Yes | 1 Participants |
| Part A: Mepitel Ag | Part B Secondary Outcome. | Day 14: Was adherence of product assessed: Yes | 6 Participants |
| Part A: Mepitel Ag | Part B Secondary Outcome. | Day 14: Was removal assessment performed: Yes | 6 Participants |
| Part A: Mepitel Ag | Part B Secondary Outcome. | Day 14: Did product stick to donor site: No | 6 Participants |