Burns, Wound Healing
Conditions
Keywords
Partial-thickness second degree burns, Mepitel Ag, Silver dressing
Brief summary
Approximately 55-65 subjects from 3-6 sites suffering from a burn injury covering 1-25% Total Body Surface Area (TBSA) will be evaluated providing they fulfill all inclusion and none of the exclusion criteria and have given a signed and dated informed consent. Study site will be from 1-15%. Each subject will be followed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. All dressing changes will be performed at the clinic and gauze rolls will be used as secondary dressing. All dressing changes will be registered in a dressing log. All subjects will be consecutively allocated to a subject code.
Detailed description
see Brief summary
Interventions
DEVICEMepitel Ag
Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject with a partial-thickness (superficial, deep or mixed) second degree burn from 1-25% TBSA * Study site is from 1-15% BSA * Study site is a single, isolated burn area * From 2 years and above * Thermal burn injury * Signed Informed Consent/Assent Form * 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
* Completely non-exuding or dry wound bed at study site * Full thickness \>5% * Burn greater than 24 hrs old * Burns to face or neck * Suspicion of infection of study burn * Use of chemical/enzymatic and biological debridement within 7 days of investigation start * Chronic steroid use, hx of skin malignancy or chronic papulosquamous disease (e.g. eczema, Pemphigus) and hx of Steven Johnson or TENS disease * Subject with lung injury or subject being on a ventilator * Subject with dermatologic skin disorders or necrotizing processes * Subject with insulin dependent diabetes mellitus * Electrical, chemical etiology * Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia), judged by the investigator to be a potential interference in the treatment * Non-compliant subject * Subject previously included in this investigation * Subject included in other ongoing clinical investigation at present or during the past 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Healed at Day 14. | Healing will be assessed after 14 days. | \> = 95 % epitheliazation |
| Proportion of Subjects Healed at Day 21. | Healing will be assessed after 21 days. | The proportion of subjects healed will be assessed at day 14. Wounds not healed at day 14 will be assessed again at day 21. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Study Burn Healed. | At day 21 | Percent of study burn healed measured by PictZar photo analysis of tissue types. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mepitel Ag Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.
Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues. | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 6 |
| Overall Study | Subject healed, not returning | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Mepitel Ag |
|---|---|
| Age, Categorical <=18 years | 17 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Age, Continuous | 25 years |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
Primary
Number of Subjects Healed at Day 14.
\> = 95 % epitheliazation
Time frame: Healing will be assessed after 14 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mepitel Ag | Number of Subjects Healed at Day 14. | 35 participants |
Primary
Proportion of Subjects Healed at Day 21.
The proportion of subjects healed will be assessed at day 14. Wounds not healed at day 14 will be assessed again at day 21.
Time frame: Healing will be assessed after 21 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mepitel Ag | Proportion of Subjects Healed at Day 21. | 37 participants |
Secondary
Percent of Study Burn Healed.
Percent of study burn healed measured by PictZar photo analysis of tissue types.
Time frame: At day 21
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mepitel Ag | Percent of Study Burn Healed. | 97.1 percentage of healing |