Donor Site Complication
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMepilex Transfer Ag
Silver dressing
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Surgical donor sites for deep partial-thickness or full-thickness burns 2. Burn of thermal origin 3. Both genders with an age ≥ 7 years at enrolment 4. Signed informed consent 5. 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
1. Any known or suspected systemic infection 2. Any known sensitivity to silver or other components/products used in this study. 3. Any active, uncontrolled, progressive or untreated malignancy. A subject who has had a malignant disease in the past, was treated with the expectation of a cure and is currently disease-free, may be considered for study entry. 4. Use of penicillamine, corticosteroid or immunosuppressive medication within 2 months prior to enrollment, or current use of nonsteroidal anti- inflammatory agents which cannot be discontinued, or who is likely to be prescribed these medications or any other medications known to adversely affect wound healing during study participation. 5. Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders. 6. Requires immersion hydrotherapy at any time during study participation (note, showering hydrotherapy is allowed). 7. Subject unwilling to comply with 28 day follow-up. 8. Participation in another investigational study while participating in this study. 9. Bleeding disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Had > 95 % Epithelialization at Day 10 | 10 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain at Dressing Changes | 28 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Mepilex Transfer Ag |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 8 |
| serious Total, serious adverse events | 1 / 8 |
Outcome results
Primary
Percentage of Participants Who Had > 95 % Epithelialization at Day 10
Time frame: 10 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mepilex Transfer Ag | Percentage of Participants Who Had > 95 % Epithelialization at Day 10 | 0 percentage of participants |
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.
Time frame: 28 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mepilex Transfer Ag | Pain at Dressing Changes | 6.0 units on a scale VAS 0-100 |