NCT01292980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2011

Completed
Last Updated

February 11, 2011

Status Verified

February 1, 2011

Enrollment Period

6 months

First QC Date

February 8, 2011

Last Update Submit

February 10, 2011

Conditions

Pressure Ulcers

Keywords

sDTIPressure ulcersTherapy surfacesMattressesDeep Tissue Injurypressure ulcer treatment

Outcome Measures

Primary Outcomes (1)

  • Degree of breakdown

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

    21 days

Interventions

AFT bedDEVICE

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

Also known as: Clinitron® Rite HiteTM bed

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who present to the hospital with SDTI

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harris Methodist Hospital

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 8, 2011

First Posted

February 10, 2011

Study Start

August 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

February 11, 2011

Record last verified: 2011-02

Locations

US(1)