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The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic foot ulcer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device, dressing | Experimental | Intervention: Device, Leia dressing |
|
| Dressing , device | Active Comparator | Intervention: Device: Hydroactive surgical dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leia | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Absorption of Wound Exudates. | Absorption capacity measured subjectively: NA/POOR/GOOD/VERY GOOD/EXCELLENT | 2-3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska clinical trial center | Gothenburg | 41346 | Sweden |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cross-over Assignment Leia | First intervention Leia, 5 Days, then second intervention Hydroactive surgical dressing 5 Days. |
| FG001 | Cross-over Assignment Hydroactive Surgical Dressing | First intervention Hydroactive surgical dressing 5 Days, then second intervention Leia, 5 Days.. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Leia and Hydroactive Surgical Dressing | In the case of this study, participants served as their own control. |
| 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 | Absorption of Wound Exudates. | Absorption capacity measured subjectively: NA/POOR/GOOD/VERY GOOD/EXCELLENT | Participants served as their own controll, those the total amount of participants is reflekted in both of the outcome measurements. | Posted | Number | Total no. assess. in each wounddressing | 2-3 weeks | Abosorbtion capacity of wounddressing | Participants |
|
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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 | Leia | Intervention: Device, Leia dressing Cross-over design, the patient was his own controll. 6 patients were treated in total. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| additional wound | Skin and subcutaneous tissue disorders | Additional wound outside target wound |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Jan Faergemann | Sahlgrenska university hospital | 031-3421000 | jan.faergemann@derm.gu.se |
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| ID | Term |
|---|---|
| D007871 | Leg Ulcer |
| D017719 | Diabetic Foot |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003925 | Diabetic Angiopathies |
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| Participants |
|
| Age, Continuous | Mean | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | Hydroactive Surgical Dressing | Intervention: Device: Hydroactive surgical dressing Cross-over design, the patient was his own controll. 6 patients were treated in total. | 0 | 6 | 0 | 6 |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |