Mixed Leg Ulcers, Venous Leg Ulcers
Conditions
Brief summary
Compare the efficacy of using an absorbent foam silver dressing (Mepilex Ag) versus the equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer with an ABPI ≥ 0.8 and with inflammatory signs. Efficacy will be defined as absolute wound size reduction.
Interventions
DEVICEMepilex Ag
Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
DEVICEMepilex without Ag
Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
Sponsors
Molnlycke Health Care AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with colonised/ local infection in a venous leg ulcer or mixed leg ulcer with an ABPI ≥ 0,8 and \< 1.3 * A history of an appropriate compression therapy for at least 2 weeks prior to randomisation * Subjects with colonised/local infection presenting with three of five following specified signs: * pain between dressing changes * exuding wounds * erythema on peri-wound skin * oedema * odour * An ulcer size of at least 4 cm2 and a maximum size witch could be covered by one investigational product of 15x15 cm. * Ulcer duration 6 weeks to 1 year * In case of multiple ulcers: target ulcer must be at least 3 cm distant from other ulcers. * Both gender with an age ≥ 18 years * Signed informed consent
Exclusion criteria
* \> 10% necrotic (black) or fibrinous (yellow) tissue covering the wound bed * Infected wounds in need of systemic antibiotic treatment * Use of anti-microbial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days from inclusion on the wound intended to be included * Previous treatment with silver product 2 weeks prior to inclusion * Previous treatment with MepilexAg® on the target ulcer * Use of systemic antibiotics for any reason during the previous 7 days * Venous surgery 2 weeks prior to inclusion or planned surgery within 8 weeks after inclusion * Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer/malignancy and severe anaemia) judged by the investigator to be a potential interference in the wound evaluation * Subjects with poorly controlled diabetes mellitus i.e. HbA1c \>8% * Subjects treated with systemic immunosuppressive or glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisolon/day or equivalent. Subjects inhaling glucocorticosteroids for asthma should not be excluded. * 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 due to poor medical condition * Participation in other clinical investigation(s) within 1 month prior to start of the investigation. * Previously randomised to this investigation. * Life expectance of the subject less than 3 months * Pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Will be Defined as Absolute Wound Size Reduction. | 8 weeks | Efficacy will be defined as absolute wound size reduction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Inflammatory Signs | 4 weeks | Change in inflammatory signs |
Countries
Czechia, France, Germany, Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mepilex Product Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds. | 101 |
| Mepilex Ag Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds. | 100 |
| Total | 201 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 8 |
| Overall Study | Death | 0 | 1 |
| Overall Study | No effect of study treatment | 3 | 1 |
Baseline characteristics
| Characteristic | Mepilex Product | Mepilex Ag | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 54 Participants | 58 Participants | 112 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants | 42 Participants | 89 Participants |
| Age, Continuous | 66.4 years STANDARD_DEVIATION 14.9 | 68.4 years STANDARD_DEVIATION 13.4 | 67.5 years STANDARD_DEVIATION 14.2 |
| Region of Enrollment Czech Republic | 47 participants | 47 participants | 94 participants |
| Region of Enrollment France | 25 participants | 26 participants | 51 participants |
| Region of Enrollment Germany | 28 participants | 26 participants | 54 participants |
| Region of Enrollment Netherlands | 1 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 54 Participants | 58 Participants | 112 Participants |
| Sex: Female, Male Male | 47 Participants | 42 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 28 / 101 | 20 / 100 |
| serious Total, serious adverse events | 2 / 101 | 4 / 100 |
Outcome results
Primary
Efficacy Will be Defined as Absolute Wound Size Reduction.
Efficacy will be defined as absolute wound size reduction.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mepilex Product | Efficacy Will be Defined as Absolute Wound Size Reduction. | -4.65 cm2 | Standard Deviation 15.43 |
| Mepilex Ag | Efficacy Will be Defined as Absolute Wound Size Reduction. | -5.09 cm2 | Standard Deviation 14.23 |
Secondary
Change in Inflammatory Signs
Change in inflammatory signs
Time frame: 4 weeks