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The objective of this investigation is to demonstrate the effectiveness and safety of Biatain Ibu non-adhesive foam dressing compared to Biatain non-adhesive foam dressing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biatain Ibu | Experimental | Biatain Ibu |
|
| Biatain | Active Comparator | Biatain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biatain | Device | A standard polyurethane foam dressing Biatain non-adhesive (Coloplast A/S) with an elastic semi-permeable backing film, size 15x15 cm. The product is CE marked. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief | The distribution of pain relief assesment during day 1 to 5. The pain relief was registrated on 5-point verbal rating scales (evening/morning) from day 1 to day 5 after start of treatment. | Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity (PI) Change | Pain intensity (PI) assesment performed daily during the days 1-5. Pain intensity assesment performed on a 11 point numerical box scale: 0 was no pain and 10 was worst possible pain. A positive outcome measure value (PI (baseline) - PI (day 4 evening)) means that PI has decreased since baseline and thus reflects clinical improvement (patients suffer less from pain). | Change from baseline in Pain Intensity (PI) on day 4 evening |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karsten Fogh, MD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus Universitetshospital | Aarhus | 8000 | Denmark | |||
| Bispebjerg Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Biatain Ibu | Biatain foam dressing containing Ibuprofen |
| FG001 | Biatain | Biatain Foam dressing without ibuprofen - control |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Biatain Ibu | Biatain foam dressing containing ibuprofen |
| BG001 | Biatain | Biatain foam dressing without ibuprofen - control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Pain Relief | The distribution of pain relief assesment during day 1 to 5. The pain relief was registrated on 5-point verbal rating scales (evening/morning) from day 1 to day 5 after start of treatment. | ITT population | Posted | Number | percentage of scores within category | Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning) | Total Number of scores day 1-5 | Total Number of scores day 1-5 |
|
6 weeks
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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 Ibu | Biatain foam dressing containing ibuprofen |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalisation due to gastritis | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Contact dermatitis in the peri-ulcer skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scientific Manager | Coloplast | +4549113557 | dkkg@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 Ibu | Device | Biatain Ibu non-adhesive (Coloplast A/S), a polyurethane foam dressing with an elastic semi-permeable backing film with an added pain relieving medicinal substance ibuprofen (Albermarle Inc.), size 15x15 cm. The product is CE marked. |
|
|
| Change From Baseline in Ulcer Area | Relative change from baseline in ulcer area using last observation carried forward. A positive outcome value Means that wound size has decreased and thus reflects wound healing (clinical improvement) | Change from baseline to end of trial (day 43) |
| Adverse Events | Number of Adverse events reported which were evaluated to be related or possible related to the device | Continuously from start of treatment to end of trial (day 43) |
| Copenhagen |
| 2400 |
| Denmark |
| Odense Universitets Hospital | Odense | 5000 | Denmark |
| CHU de Brest | Arras | 62000 | France |
| CHU de Nancy - Hôpital Fournier | Nancy | 54035 | France |
| Department for Dermatology, University School of Medicine | Essen | 45122 | Germany |
| Georg-August-Universität Göttingen | Göttingen | 37075 | Germany |
| Klinik für Dermatologie und Venerologie | Hanover | 30449 | Germany |
| Universitätsklinikum des Saarlandes | Homburg/Saar | 66421 | Germany |
| Dr. Renzo Bause Praxis | Lüdenscheid | 58511 | Germany |
| Fachartzpraxis für Dermatologie, Allergologie, Lasermedizin | Mahlow | 15831 | Germany |
| C.S. SERGAS Rosalía de Castro - Enfermero | Vigo | Pontevedra | 36201 | Spain |
| Hospital de Fuenlabrada | Fuenlabrada | 28942 | Spain |
| Withdrawal by Subject |
|
| ulcer healed |
|
| Other reason |
|
| BG002 | Total | Total of all reporting groups |
| YEARS |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Total Number of scores day 1-5 |
|
|
|
| Secondary | Pain Intensity (PI) Change | Pain intensity (PI) assesment performed daily during the days 1-5. Pain intensity assesment performed on a 11 point numerical box scale: 0 was no pain and 10 was worst possible pain. A positive outcome measure value (PI (baseline) - PI (day 4 evening)) means that PI has decreased since baseline and thus reflects clinical improvement (patients suffer less from pain). | PP-population (The PP population consisted of all randomized subjects that fulfilled the inclusion/exclusion criteria and which did not violate the protocol in a serious way day 1-5) - Evaluation performed on un-blinded data before database lock. | Posted | Mean | Standard Deviation | Change in PI since baseline | Change from baseline in Pain Intensity (PI) on day 4 evening |
|
|
|
| Secondary | Change From Baseline in Ulcer Area | Relative change from baseline in ulcer area using last observation carried forward. A positive outcome value Means that wound size has decreased and thus reflects wound healing (clinical improvement) | ITT population | Posted | Median | Standard Deviation | Relative change from baseline in percent | Change from baseline to end of trial (day 43) |
|
|
|
| Secondary | Adverse Events | Number of Adverse events reported which were evaluated to be related or possible related to the device | Posted | Number | Number of AE | Continuously from start of treatment to end of trial (day 43) |
|
|
|
| 0 |
| 60 |
| 4 |
| 60 |
| EG001 | Biatain | Biatain foam dressing without ibuprofen | 1 | 60 | 6 | 60 |
| Increased pain in study ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Blisters at the edge of the dressing | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Infection in study ulcer | Infections and infestations | Non-systematic Assessment |
|
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