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the objective of this investigation is to demonstrate the effect of the foam dressing Biatain Ag, compared to Biatain foam dressing( a product which is similar but does not contain a silver complex, in the healing of leg ulcers that had failed to heal despite appropriate therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Biatain Ag dressing |
|
| 2 | Active Comparator | Biatain dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biatain Ag | Device | Biatain Ag non adhesive ( ColoplastA/S), a polyurethane permeable backing film with an added silver complex, size 15X15. The product is CE marked |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline | The measure of the ulcer was to measure its greatest lenght and width with these two axes being at right angles. An average of three measurements was to calculated the area of the ulcer by the equation: Area= Lenght *Width * pi [3.142] / 4 All planimetry records (using double-sided tracing paper) were centrally assessed and read by a blinded person not aware of which treatment that was used. | Day 0 to Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 10 Compared to the Ulcer Area at Baseline | The measure of the ulcer was to measure its greatest lenght and width with these two axes being at right angles. An average of three measurements was to calculated the area of the ulcer by the equation: Area= Lenght *Width * pi [3.142] / 4 All planimetry records (using double-sided tracing paper) were centrally assessed and read by a blinded person not aware of which treatment that was used. |
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Inclusion Criteria:
• Patients over 18 who have given written informed consent
Exclusion Criteria:
• Patients whose leg ulcers are clinically infected (including erysipelas and cellulitis of the skin around the ulcer) requiring systemic antibiotic treatment
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Patients could be in-patients, out-patients attending hospital clinics specialising in phlebo-angiology, dermatology or vascular surgery, or patients being treated in a non-hospital setting
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| ID | Title | Description |
|---|---|---|
| FG000 | Biatain Ag Wound Dressing | Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver |
| FG001 | Biatain Wound Dressing | Biatain dressing is a foam wound dressing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Biatain Ag Wound Dressing | Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver |
| BG001 | Biatain Wound Dressing | Biatain dressing is a foam wound dressing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline | The measure of the ulcer was to measure its greatest lenght and width with these two axes being at right angles. An average of three measurements was to calculated the area of the ulcer by the equation: Area= Lenght *Width * pi [3.142] / 4 All planimetry records (using double-sided tracing paper) were centrally assessed and read by a blinded person not aware of which treatment that was used. | A total of 182 subjects were randomised in the study (safety analysis set), however one patient was in systemic antibiotic treatment and was erroneously enrolled, hence the ITT analysis set comprised 181 subjects. | Posted | Mean | Standard Deviation | Percentage change | Day 0 to Day 42 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Biatain Ag Wound Dressing | Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Social circumstances | Non-systematic Assessment | Unlikely related to device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Maceration - eczema - redness - pain of wound and peri-wound skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Often AEs in form of maceration of the wound and peri-wound skin are reported together with redness, eczema and pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Birte Petersen Jacobsen | Coloplast | 004549110000 | 1395 | DKBIR@coloplast.com |
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| ID | Term |
|---|---|
| D007871 | Leg Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Biatain | Device | A standard polyurethane foam dressing Biatain non adhesive permeable backing film, size15X15 cm. the product is CE marked |
|
| Day 0 to Day 70 |
| Total Number of Adverse Events | Day 0 to Day 70 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Biatain Wound Dressing | Biatain dressing is a foam wound dressing |
|
|
| Secondary | Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 10 Compared to the Ulcer Area at Baseline | The measure of the ulcer was to measure its greatest lenght and width with these two axes being at right angles. An average of three measurements was to calculated the area of the ulcer by the equation: Area= Lenght *Width * pi [3.142] / 4 All planimetry records (using double-sided tracing paper) were centrally assessed and read by a blinded person not aware of which treatment that was used. | ITT (ANCOVA) - LOCF was applied for subjects not having a value at visit 3 but a value at visit 2 for the ulcer area | Posted | Mean | 95% Confidence Interval | Percentage change | Day 0 to Day 70 |
|
|
|
| Secondary | Total Number of Adverse Events | Posted | Number | Adverse Event | Day 0 to Day 70 |
|
|
|
| 5 |
| 88 |
| 4 |
| 88 |
| EG001 | Biatain Wound Dressing | Biatain dressing is a foam wound dressing | 7 | 94 | 2 | 94 |
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Unlikely related to device |
|
| cardiac decompression | Cardiac disorders | Non-systematic Assessment | left-complete arrythmia by artrial fibrillation. Unlikely related to device |
|
| Recurrance opposite leg mlum perforans pedis infection | Infections and infestations | Non-systematic Assessment | Unlikely related to device |
|
| pneumoccal pneumonia hypoxemiante | Infections and infestations | Non-systematic Assessment | Unlikely related to device |
|
| Arteriopathie left lower limb | Vascular disorders | Non-systematic Assessment | Unlikely related to device |
|
| acute pulmonary edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Unlikely related to device |
|
| important pain on right leg | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unlikely related to device |
|
| Artheriography planned | Investigations | Non-systematic Assessment | Unlikely related to device |
|
| Alteration of general state | Social circumstances | Non-systematic Assessment | Unlikely related to device |
|
| Attack of angina | Cardiac disorders | Non-systematic Assessment | Unlikely related to device |
|
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment | Unlikely related to device. The patient died due to the cardiact arrest |
|
|
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| Moderate, not related |
|
| moderate, possibly related |
|
| moderate, related |
|
| severe, not related |
|
| severe, possibly related |
|
| severe, related |
|
| not specified, not related |
|