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A Multi-Centre, Open, Non-controlled, Clinical Investigation to Evaluate the User Friendliness and Wear Time of Multi-layer Foam Dressings With Safetac® for Pressure Injury Prevention in the Intensive Care Unit
This was a multi-centre, open, non-comparative, prospective, clinical investigation involving 50 enrolled subjects using competitive enrolment at two sites in the United States of America (USA). The study was conducted on subjects at risk of developing PIs according to investigators' judgment and facility protocol being treated in ICUs. The target subjects were male and female, 18 years and above, with an expected hospital stay of 4-6 days. An evaluable subject was defined as a subject that was enrolled and had data for at least one visit after the baseline visit. There were two parts to the study: Part A: Mepilex Border/Protect Sacrum; Part B: Mepilex Border/Protect Heel (on both left and right heels), used within intended use and according to IFU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A. Mepilex Border Sacrum (Safetac) | Experimental | A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area at pressure points in patients in the ICU, prone to get pressure injuries (PI). |
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| B. Mepilex Border Heel (Safetac) | Experimental | A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the heels (on both left and right heels), in patients in the ICU, prone to get pressure injuries (PI). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepilex Border | Device | Multi-layer Foam Dressings |
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| Measure | Description | Time Frame |
|---|---|---|
| User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication | User friendliness judged by site staff, with the following variables; Ability to stay in place Facilitation of inspection Ease of reapplication Conformability to the body Overall impression of dressing *NOTE: Since subjects typically left the ICU earlier than expected (the study protocol stipulated that the test dressing should be left in place for 3 days or longer, however typically the subjects left the ICU department after one day), not all subjects completed the full study period/all study visits. Furthermore, since not all assessment visits were completed for each subject or a dressing change was not required, the total number of all visits exceeds the total number for each variable. This was because the subject did not undergo a dressing application/removal or that the question was not relevant at a given visit (some questions were only relevant for dressing applications, some questions were only relevant for dressing removals or only relevant for dressing inspections). | 4-6 days |
| User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication | User friendliness judged by site staff, with the following variables; How do you prefer this dressing to your current dressing? *NOTE: Since subjects typically left the ICU earlier than expected (the study protocol stipulated that the test dressing should be left in place for 3 days or longer, however typically the subjects left the ICU department after one day), not all subjects completed the full study period/all study visits. Furthermore, since not all assessment visits were completed for each subject or a dressing change was not required, the total number of all visits exceeds the total number for each variable. This was because the subject did not undergo a dressing application/removal or that the question was not relevant at a given visit (some questions were only relevant for dressing applications, some questions were only relevant for dressing removals or only relevant for dressing inspections). | 4-6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Wear Time (Days) for First Dressing | Maximum length of wear time/stay on ability of dressings in ICU. | 4-6 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelli Potter, BSN, RN | AnMed Health Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anmed Health | Anderson | South Carolina | 29621 | United States | ||
| Roper Hospital |
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Investigation period: Sept 2016 - Nov 2016. This study was conducted in two sites in the US, on patients being treated in an ICU who were at risk of developing pressure injuries.
The target subjects were male or female, aged 18 years or above, with an expected stay of 4-6 days in an ICU.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mepilex Border Dressing All | A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI). Mepilex Border: Multi-layer Foam Dressings |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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ITT population
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| ID | Title | Description |
|---|---|---|
| BG000 | Mepilex Border Dressing Heel and Sacrum Together | A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI). Mepilex Border: Multi-layer Foam Dressings |
| 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 | User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication | User friendliness judged by site staff, with the following variables; Ability to stay in place Facilitation of inspection Ease of reapplication Conformability to the body Overall impression of dressing *NOTE: Since subjects typically left the ICU earlier than expected (the study protocol stipulated that the test dressing should be left in place for 3 days or longer, however typically the subjects left the ICU department after one day), not all subjects completed the full study period/all study visits. Furthermore, since not all assessment visits were completed for each subject or a dressing change was not required, the total number of all visits exceeds the total number for each variable. This was because the subject did not undergo a dressing application/removal or that the question was not relevant at a given visit (some questions were only relevant for dressing applications, some questions were only relevant for dressing removals or only relevant for dressing inspections). | ITT population As a dressing change was not required at all visits, the total number of dressing changes evaluated vary for each variable and a question was perhaps not relevant at a given visit (some questions were only relevant for dressing applications, some were only relevant for dressing removals or only relevant for dressing inspections). | Posted | Count of Units | Dressing changes evaluated |
Through study completion, an average of 2 months.
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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 | Mepilex Border Dressing All | A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI). Mepilex Border: Multi-layer Foam Dressings |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Research Director | Molnlycke Health Care | +46 31 722 30 00 | info@monlycke.com |
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| Charleston |
| South Carolina |
| 29401 |
| United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
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| 4-6 days |
| Dressing changes evaluated |
| Dressing changes evaluated |
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| Primary | User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication | User friendliness judged by site staff, with the following variables; How do you prefer this dressing to your current dressing? *NOTE: Since subjects typically left the ICU earlier than expected (the study protocol stipulated that the test dressing should be left in place for 3 days or longer, however typically the subjects left the ICU department after one day), not all subjects completed the full study period/all study visits. Furthermore, since not all assessment visits were completed for each subject or a dressing change was not required, the total number of all visits exceeds the total number for each variable. This was because the subject did not undergo a dressing application/removal or that the question was not relevant at a given visit (some questions were only relevant for dressing applications, some questions were only relevant for dressing removals or only relevant for dressing inspections). | ITT population As a dressing change was not required at all visits, the total number of dressing changes will vary for each variable and a question was perhaps not relevant at a given visit (some questions were only relevant for dressing applications, some were only relevant for dressing removals or only relevant for dressing inspections). | Posted | Count of Units | Number of dressing changes | 4-6 days | Number of dressing changes | Number of dressing changes |
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| Secondary | Wear Time (Days) for First Dressing | Maximum length of wear time/stay on ability of dressings in ICU. | ITT population | Posted | Count of Participants | Participants | 4-6 days |
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| 4 |
| 50 |
| 7 |
| 50 |
| 1 |
| 50 |
| Prolongation of existing hospitalization | Infections and infestations | Systematic Assessment | Subject developed sepsis related to possible pneumonia on 18Nov2016. Mechanical ventilation weaning and vasopressor medication weaning were delayed, thus prolonging the subject's hospitalization. |
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| Bowel perforation | Gastrointestinal disorders | Systematic Assessment | Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function |
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| Worsening Sepsis | Infections and infestations | Systematic Assessment |
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| Possible pneumonia and sepsis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Good |
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| Very Good |
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| Excellent |
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| Equal to |
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| Not as good as |
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| 2 Days |
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| 3 Days |
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| 4 Days |
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| 5 Days |
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