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A post market clinical follow-up study investigating the safety of Biatain Silicone Sacral while used as prevention in hospital admitted patients at risk of developing a pressure injury.
The investigation was a multi-centre, open label, non-comparative, single-arm, prospective study, conducted at three investigational sites in Danish hospitals. 67 hospital-admitted patients were enrolled in the study over a 3-month recruitment period. The target population were patients ≥18 years of age with an expected hospital-stay of more than 24 hours from baseline and a Braden score of 6-18.
At daily visits skin inspections for signs of non-blanchable erythema or sacral pressure injury were performed by partial lift and reapplication of the dressing. After 7 days, or earlier if the patient was discharged, a termination visit was performed. Skin assessment was performed upon removal of the dressing and a termination form completed. Information regarding adverse events and device deficiencies were collected at all visits.
There were no follow-up visits after termination of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biatain Silicone Sacral Dressing | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biatain Silicone Sacral dressing | Device | Biatain Silicone Sacral dressing will be applied over the bony prominence of the sacral area as part of a PIP (Pressure Injury Prevention) protocol in patients at risk |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | Evaluate the safety of Biatain Silicone Sacral. Adverse events considered related to the investigational device by the investigator during the investigation period (up to 7 days or until discharged) | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Device Deficiencies | Evaluate the safety of Biatain Silicone Sacral. Number of device deficiencies during the investigation period (up to 7 days or until discharged) | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Overgaard, SSM | Coloplast A/S | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Copenhagen | Denmark | ||||
| Herlev Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Biatain Silicone Sacral Dressing | Biatain Silicone Sacral will be applied over the bony prominence of the sacral area |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Numbers of participants constitutes the ITT population (participants exposed to the investigational device with information on at least one endpoint) and differ from the overall (safety population constituted by all subjects with a valid informed consent)
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| ID | Title | Description |
|---|---|---|
| BG000 | Biatain Silicone Sacral Dressing | Biatain Silicone Sacral will be applied over the bony prominence of the sacral area |
| 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 | Number of Adverse Events | Evaluate the safety of Biatain Silicone Sacral. Adverse events considered related to the investigational device by the investigator during the investigation period (up to 7 days or until discharged) | Posted | Number | Adverse events | 7 days |
|
|
Adverse events were collected from baseline (day 1, visit 1) and at all daily visits until termination visit (latest after 7 days). There was no follow-up after study termination.
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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 Silicone Sacral Dressing | 67 patients were treated with Biatain Silicone Sacral dressing over the bony prominence of the sacral area as part of a pressure injury prevention protocol |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Worsening of shortness of breath. Event assessed as not related to the investigational device by the investigator |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incision site pain | Nervous system disorders | Systematic Assessment | All events assessed as not related to the investigational device by the investigator |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Scientific Manager | Coloplast | +45 49112880 | dkcpov@coloplast.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2023 | May 2, 2024 | Prot_SAP_000.pdf |
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Open-labelled, non-comparative, single-arm, prospective, multi-center investigation.
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| Copenhagen |
| Denmark |
| Hvidovre Hospital | Copenhagen | Denmark |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Mean | Full Range | kg/m2 |
|
| Urinary incontinence | Count of Participants | Participants |
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| Faecal incontinence | Count of Participants | Participants |
|
| Braden Scale Score | The Braden Scale is a standardized assessment tool used in healthcare to assess a patient's risk for developing pressure injuries. The total Braden Scale score ranges from 6 to 23, with lower scores indicating higher susceptibility to pressure ulcers | Mean | Full Range | scores on a scale |
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| Secondary | Number of Device Deficiencies | Evaluate the safety of Biatain Silicone Sacral. Number of device deficiencies during the investigation period (up to 7 days or until discharged) | Posted | Number | Device deficiencies | 7 days |
|
|
|
| 1 |
| 67 |
| 4 |
| 67 |
| 5 |
| 67 |
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| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Patient admitted with end stage cirrhosis or cancer of the liver. Event assessed as not related to the investigational device by the investigator |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Aspiration to the lungs in conjunction with gastroscopy. Event assessed as not related to the investigational device by the investigator |
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| Intraabdominal bleeding | Surgical and medical procedures | Systematic Assessment | patient experienced intraabdominal bleeding following a total colectomy due to ulcerative colitis. Event assessed as not related to the investigational device by the investigator |
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