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Completed Not applicable Interventional

AFT/CLP-LAL RCT Stage 3 or 4 Pressure Injuries

ClinicalTrials.gov ID: NCT03463434

Public ClinicalTrials.gov record NCT03463434. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 8:02 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized Controlled Pilot Study Comparing Air Fluidized Therapy (AFT) to a Continuous Low Pressure (CLP) Low Air Loss (LAL) Support Surface in the Treatment of Stage 3 or 4 Pressure Injuries

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03463434
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Hill-Rom
Industry
Enrollment
5 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 9, 2018
Primary completion
Aug 13, 2019
Completion
Aug 13, 2019
Last update posted
Aug 14, 2019

2018 – 2019

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
2
Facility City State ZIP Site status
Noland Health Anniston Anniston Alabama 36207
Noland Health Birmingham Alabama 35242

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

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About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03463434, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 14, 2019 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03463434 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →