Burns, Inflammation, Ulcers
Conditions
Keywords
The change in signs of inflammation/local infection, To evaluate the comfort, conformability,, Pain during wear
Brief summary
The purpose of this study is to evaluate the change in signs of inflammation/local infection when Mepilex Border Ag is used in normal clinical practice when used on chronic ulcers (venous leg, diabetic foot and pressure ulcers) and partial thickness burns in need\* of topical antimicrobial treatment according to the physician.
Detailed description
The investigation is designed as an open, non-controlled, post-marketing clinical follow-up. Subjects with chronic ulcers or partial thickness burns (including donor sites) at 2 sites will be included. Each subject with a chronic ulcer will be seen once a week for a maximum of 4 weeks or until desired treatment effect is obtained, whichever occurs earlier. Each subject with a partial thickness burn/donor site will be followed once a week for a maximum of 3 weeks or until desired treatment effect is obtained, whichever occurs earlier. All dressing changes will be done according to clinical routine practices and will follow IFU (instruction for use)
Interventions
DEVICEMepilex Border Ag
Mepilex Border Ag may be left in place for up to seven days, depending on the condition.
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject with a chronic ulcer (venous leg, diabetic foot and pressure ulcers) or a partial thickness burn where an antimicrobial action is indicated\* as judged by the investigator * Male or female, 18 years and above, both in- and out-patients * Signed Informed Consent Form
Exclusion criteria
* Wound size equal to or above 9.5x15cm for the wound/burn to be included in the investigation * Subject not expected to follow the investigation procedures * TBSA \> 10% (partial thickness burns only) * HbA1C value \> 7.2. (To be measured if BMI \> 30) * Pregnant and breastfeeding women * Pressure ulcers deeper than stage 3 * Deep pressure ulcers in need of a filler * Subjects with known sensitivity to silver or any other dressing materials * Subjects receiving radiation treatment or examinations e.g. X-ray, ultrasound, diathermy or Magnetic Resonance Imaging * Subjects using oxidising agents such as hypochlorite solutions or hydrogen peroxide * Subjects previously included in this investigation * Subjects included in other ongoing clinical investigation at present or during the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Are at Baseline | Baseline | — |
| Wound Area at Visit 2 | After one week | At each visit the wound length and width is measured and calculated in cm2. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mepilex Border Ag Non comparative study with one active arm - Mepilex Border Ag
Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition. | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Mepilex Border Ag |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age Continuous | 57.3 years STANDARD_DEVIATION 17.2 |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
Wound Area at Visit 2
At each visit the wound length and width is measured and calculated in cm2.
Time frame: After one week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mepilex Border Ag | Wound Area at Visit 2 | 43.0 cm2 | Standard Deviation 41.6 |
Primary
Wound Are at Baseline
Time frame: Baseline