Air Fluidized Therapy (AFT) in Patients With Suspected Deep Tissue Injury (sDTI)

Air Fluidized Therapy Use in Patients Who Present With Suspected Deep Tissue Injury - a Case Series

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01292980

Enrollment

Registered

2011-02-10

Start date

2010-08-31

Completion date

2011-02-28

Last updated

2011-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcers

Keywords

sDTI, Pressure ulcers, Therapy surfaces, Mattresses, Deep Tissue Injury, pressure ulcer treatment

Brief summary

Patients with a suspected Deep Tissue Injury (or a purple reddened area over a bony prominence of their body, which is expected to break down into a pressure ulcer) will be place on the Clinitron® Rite HiteTM bed to see if the air fluidized mattress decreases the amount of tissue breakdown from their bruise.

Detailed description

Up to 15 centers will participate in this case series in acute care and long term acute care facilities. Patients who present with sDTI and consent for study will have the Clinitron® Rite HiteTM bed ordered and delivered within a 12 hour window to be able to participate. They will have their sDTI photographed, and an assessment of expected breakdown will be noted by the clinical team. The patient will be followed during the course of hospitalization and additional photographs and documentation will be performed by the clinical team to demonstrate the actual breakdown that occurred. Information including the pertinent history of current illness, co-morbid conditions, and demographic information will be shared with the sponsor in order to demonstrate each case.

Interventions

DEVICEAFT bed

All identified patients will receive a AFT bed for a maximum of 21 days or until discharge

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

1. Patients with sDTI on the supine aspect of their body 2. Patient does not require a pulmonary specialty bed for care 3. Patient is expected to be in the hospital for at least 3 days 4. Patient weighs between 30 and 350 Lbs. 5. Patient's height is less than 75 inches tall 6. Patient, or patient's representative, is willing and able to sign written informed consent 7. Patient is expected to survive hospitalization.

Exclusion criteria

1. Patient is less than 18 years of age 2. Patient has already participated in this study

Design outcomes

Primary

Measure	Time frame	Description
Degree of breakdown	21 days	This case series seeks to identify patients with suspected DTI and capture actual patient outcomes with AFT treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026