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NCT03463434 · ClinicalTrials.gov registry record · NA
AFT/CLP-LAL RCT Stage 3 or 4 Pressure Injuries
A NA study of Pressure Ulcer, sponsored by Hill-Rom.
- Completed
- Registry status
- NA
- Development phase
- 5
- Enrollment target
- 2
- Study locations
NCT03463434 is a NA study of Pressure Ulcer that has completed, run by Hill-Rom. The registered enrollment target is 5 participants, below the 30,116-participant average among 10 other Pressure Ulcer trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT03463434, a NA study of Pressure Ulcer, has completed, sponsored by Hill-Rom.
- COMPLETED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Air Fluidized Therapy
- DEVICE Continuous Low Pressure-LAL
Study Locations (2)
Alabama
- Noland Health Anniston - Anniston
- Noland Health - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-05-10 |
| Est. Completion | 2019-08-14 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03463434
The ClinicalTrials.gov registry entry for NCT03463434 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 30,116-participant average among 10 other Pressure Ulcer trials with a reported enrollment target (100% lower). The listed sponsor is Hill-Rom, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pressure Ulcer appearing as the primary indexed condition, and to 2 interventions - of which Air Fluidized Therapy is the first listed.
NCT03463434 reports 2 study locations spanning 1 distinct geographic area - top geographies include Alabama.
Frequently Asked Questions
What is clinical trial NCT03463434 about?
NCT03463434 is a clinical study titled "AFT/CLP-LAL RCT Stage 3 or 4 Pressure Injuries". 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 select...
What is the current status of trial NCT03463434?
This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2018-05-10. Estimated completion is 2019-08-14.
What conditions does trial NCT03463434 study?
This clinical trial studies the following conditions: Pressure Ulcer.
What interventions are being tested in trial NCT03463434?
The interventions under investigation include: Air Fluidized Therapy (DEVICE), Continuous Low Pressure-LAL (DEVICE).
Who is sponsoring clinical trial NCT03463434?
This trial is sponsored by Hill-Rom, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03463434 being conducted?
This trial has 2 study locations across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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