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| ID | Type | Description | Link |
|---|---|---|---|
| Window 02 |
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The rational for the study is to add a thin self-adherent dressing on critically ill patients. Evaluate if the dressing might protect the skin for further breakdown.Participants will be followed for the duration of hospital stay, an expected average of 5 days.
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| Measure | Description | Time Frame |
|---|---|---|
| Erythema (No/Yes) | Measure number of skin breakdown during from enrolment to termination. | During 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Experience of Use of the Dressing | Overall experience of use of the dressing rated on a scale from Very Poor, Poor, Good, Very Good, Excellent | During 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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Critically ill patients at ICU.
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| Name | Affiliation | Role |
|---|---|---|
| Jan Faergemann, Professor | Dermatology Department Sahlgrenska University Gothenburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Department | Gothenburg | Sweden |
There was no wash-out or run-in phase included in the study.
The recruitment period was from 17 May 2011 - 29 June 2011. The study was conducted at four intensive care units in Sweden.
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| ID | Title | Description |
|---|---|---|
| FG000 | Window | WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time. Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Window | WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time. Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Erythema (No/Yes) | Measure number of skin breakdown during from enrolment to termination. | Posted | Number | participants | During 5 days |
|
Adverse Event were collected from enrollment to termination ( 5 days)
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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 | Window | WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time. Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Vascular disorders | Systematic Assessment | Serious medical condition with multiple organ failure after acute abdominal aortic aneurysm rupture with a bleeding of 28000ml. The patient condition deteriorated despite intensive care treatment with ventilator, dialysis and vasopressor drugs. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Brady cardia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tina Kjellen | Molnlycke Health Care AB | +46317223098 | tina.kjellen@molnlycke.com |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Overall Experience of Use of the Dressing | Overall experience of use of the dressing rated on a scale from Very Poor, Poor, Good, Very Good, Excellent | Posted | Number | participants | During 5 days |
|
|
|
| 1 |
| 24 |
| 7 |
| 24 |
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| Pressure Ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pneumoni | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Tachy Cardia | Cardiac disorders | Systematic Assessment |
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| Arterial Flutter | Cardiac disorders | Systematic Assessment |
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| Thromboflebitis in right arm | Infections and infestations | Systematic Assessment |
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| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Title | Measurements |
|---|
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| Very good |
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| Excellent |
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