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

NCT03463434 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-08-15

No results posted yet for this 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

  • Pressure Ulcer

Interventions

DEVICE

Air Fluidized Therapy

AFT bed used for pressure injury treatment

DEVICE

Continuous Low Pressure-LAL

Continuous Low Pressure/Low Air Loss Mattress for Pressure injury treatment

Sponsors & Collaborators

  • Hill-Rom

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-10
Primary Completion
2019-08-14
Completion
2019-08-14

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03463434 on ClinicalTrials.gov