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Patients who have at least one stage 3 or 4 PI and are admitted to a participating treating facility will be candidates for study enrollment. Patients must provide written informed consent. Standard care for their admitted condition will be provided for the patients except for support surface selection, laboratory blood tests, PI measurement(s) by the 3-D camera measurement tool, and added pain and patient satisfaction assessments. Clinical assessments will be recorded weekly as described below. Patients will be followed until discharge from the LTACH or until 1) they require a different mattress for their admitted condition; or 2) reach a maximum of 12 weeks in the LTACH. At study discontinuation, a clinical general assessment of the quality of improvement of the PIs will be recorded.
Patients admitted to the LTACH with at least one stage 3 or 4 PI will be evaluated for possible inclusion/exclusion criteria. Patients will be approached by the investigator, or their designee to acquire patient informed consent. If provided, patients will be randomized to their designated support surface, the bed will be ordered and patients will begin the study with a baseline study visit (week 0) that will include:
Subsequent weekly study visits will continue for a maximum of 12 weeks. The interim study visit documentation will include:
Clinical Resource Utilization Data: documentation of the following data will aim to achieve estimated clinical resources associated with caring for PIs:
At study discharge, which may occur at the time of study PI healing, LTACH discharge, or upon stepdown from the randomized study surface) or for other reasons, a final study visit will be completed that includes:
Date and time of study bed removal
Overall health status assessment,
Skin assessment to document any new PI's that may have developed,
Braden PU risk assessment (includes subscores),
3D wound assessments of all truncal PI's,
Clinical assessment of signs and symptoms of wound infection
Confirmation of bed support surface type
Documentation of adverse device effects, device related complaints (within 24 hours of effect/complaint).
Clinical Resource Utilization Data:
Assessment of pain
A patient bed satisfaction assessment will be completed if the patient is able to communicate
Blood for CBC, Albumin, Pre-Albumin, CRP will be collected
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Air Fluidized Therapy | Experimental | Patients will be placed on the Envella AFT bed |
|
| Continuous Low Pressure-LAL | Active Comparator | Patients will receive a Continuous low pressure mattress with low air loss |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Air Fluidized Therapy | Device | AFT bed used for pressure injury treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pressure ulcer healing | Volume (mm3) | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| New Pressure Ulcers | new pressure ulcers | up to 12 weeks |
| Length of stay | Length of stay in the Long-term Acute Care Hospital | up to a year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Noland Health Anniston | Anniston | Alabama | 36207 | United States | ||
| Noland Health |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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This multi-center, randomized, open-label, two treatment, parallel group study is designed to obtain comparative data on the healing rates of type 3 & 4 pressure injuries.
The randomization schedule will be set up in blocks, and within a block, the randomization numbers will be assigned equally to the two treatment groups (Envella AFT, FIS bed surface types). A separate randomization schedule will be set up for each stage (3, 4 PI). The anticipated number of investigative sites is 3.
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| Continuous Low Pressure-LAL |
| Device |
Continuous Low Pressure/Low Air Loss Mattress for Pressure injury treatment |
|
| Birmingham |
| Alabama |
| 35242 |
| United States |