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OpenTrials
Completed

NCT Number: NCT01292980

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Harris Methodist Hospital

Fort Worth, Texas, 76104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient is less than 18 years of age
  • Patient has already participated in this study

Treatment and study plan

AFT bed

Device

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

Other names: Clinitron® Rite HiteTM bed

Primary outcomes

  1. Degree of breakdown

    Time frame: 21 days

    This case series seeks to identify patients with suspected DTI and capture actual patient outcomes with AFT treatment

Sponsors and collaborators

Lead sponsor

Hill-Rom

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 10, 2011
Registry last updated
Feb 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.