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This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system. The primary objective is to evaluate the performance of the dressing when used as intended on exuding Venous Leg Ulcers (VLUs) in the inflammatory and granulating stages of the wound healing process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | Active Comparator | standard care ( such as alginate, hydrofiber or other treatment) |
|
| Intervention ( Mepilex XT) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepilex XT | Device | Experimental arm |
| |
| standard care |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in Condition of the Peri Wound Skin | Deteriorationin of skin condition , Mepilex XT and Standard care (%) | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores on the Visual Analog Scale | Pain at baseline visit, compared with pain at week 16. VAS scale, minimum pain = 0, maximum pain = 100. | 16 weeks |
| Users Feedback After Handling or Use as a Measure of Performance. |
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Inclusion Criteria:
Venous Leg Ulcer
Exuding wound
Wound surface covered with sloughy tissue* (before debridement)
Wound size ≥ 6 cm2
In case of multiple wounds, target wound must be ≥ 3cm distant from other wounds.
Wound suitable for treatment with the relevant primary dressing**
Male or female, 18 years of age and above
Signed Informed Consent
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemocnice Podlesà a.s. | Třinec | Konská 453 | 739 61 | Czechia | ||
| Nemocnice Jihlava |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care | standard care ( such as alginate, hydrofiber or other treatment) standard care |
| FG001 | Intervention ( Mepilex XT) | Mepilex XT: Experimental arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Other |
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Investigator/Nurse and Subject evaluation of performance of the primary dressing ( n) Scale= Good , Very Good, Poor, Very Poor
1Ease of application, 2 Ease of removal, 3 Ability to retain exudate, 4 Adherence to healthy skin, 5 Confomability to be repositioned , 6 Overall satisfaction, 7 Dressing sticking to wound bed, 8 Presence of residues on the wound bed. 9 Presence of residues on the healthy skin. 10 Overall evaluation of change in periwound skin condition.
| 16 weeks |
| Measure of Actual Dressing Cost and Cost of Care, as Input for Health Economics Calculations. | 16 weeks |
| Jihlava |
| Vrchlického |
| 586 01 |
| Czechia |
| The General University Hospital in Prague | Prague | Czechia |
| COMPLETED |
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| NOT COMPLETED |
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All subjects that have used at least one product and that have some follow-up data for the primary endpoint is included in the population presented.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | standard care ( such as alginate, hydrofiber or other treatment) standard care |
| BG001 | Intervention ( Mepilex XT) | Mepilex XT: Experimental arm |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Changes From Baseline in Condition of the Peri Wound Skin | Deteriorationin of skin condition , Mepilex XT and Standard care (%) | Intention to treat, change from baseline in condition of the peri-wound skin. | Posted | Number | percentage of subjects | 16 weeks |
|
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| Secondary | Pain Scores on the Visual Analog Scale | Pain at baseline visit, compared with pain at week 16. VAS scale, minimum pain = 0, maximum pain = 100. | Posted | Mean | Standard Deviation | units on a scale (VAS) | 16 weeks |
|
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| Secondary | Users Feedback After Handling or Use as a Measure of Performance. | Investigator/Nurse and Subject evaluation of performance of the primary dressing ( n) Scale= Good , Very Good, Poor, Very Poor 1Ease of application, 2 Ease of removal, 3 Ability to retain exudate, 4 Adherence to healthy skin, 5 Confomability to be repositioned , 6 Overall satisfaction, 7 Dressing sticking to wound bed, 8 Presence of residues on the wound bed. 9 Presence of residues on the healthy skin. 10 Overall evaluation of change in periwound skin condition. | Posted | Number | participants | 16 weeks |
|
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| Secondary | Measure of Actual Dressing Cost and Cost of Care, as Input for Health Economics Calculations. | the way to collect data differed to much betwen the sites, no analysis could be done. | Posted | 16 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 | Standard Care | standard care ( such as alginate, hydrofiber or other treatment) standard care | 0 | 9 | 0 | 9 | ||
| EG001 | Intervention ( Mepilex XT) | Mepilex XT: Experimental arm | 0 | 21 | 3 | 21 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low pain in the skin under dressing | Skin and subcutaneous tissue disorders | skin and subcutaneou | Non-systematic Assessment | unlikely relattionship to dressing |
|
| wound infection | Skin and subcutaneous tissue disorders | wound infection | Non-systematic Assessment | superficial wound infection |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| MuDr Jan Stryja | Nemocnice Podlesà | +420 558 304 111 | Jan.stryja@atlas.cz |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| >=65 years |
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| Male |
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| Maceration |
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| Dermatitis |
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| Blistering |
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| skinstripping |
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| Trauma to wound edges |
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| Product degradation |
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