Deep Tissue Injury Treatment With MIST Therapy Versus Standard Care: REVERSE DTI Study
Stopped early · Not applicable
Conditions studied: Wound of Skin
In brief
The purpose of this study is to evaluate the effectiveness of MIST Therapy in conjunction with standard of care (SOC) compared to SOC alone in the prevention of deep tissue injury (DTI) progression to advanced stage pressure ulcers.
Key facts
- Study ID
- NCT01540981
- Run by
- Celleration, Inc.
- People needed
- 12
- Starts
- 2012-02-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2015-01-15
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female subject of any race 18-90 years old.
- Subject presents with an index DTI. This is defined by the National Pressure Ulcer Advisory Panel (NPUAP) as a purple or maroon localized area of discolored intact skin or blood-filled blister due to damage of underlying soft tissue from pressure and/or shear. The area may be preceded by tissue that is painful, firm, mushy, boggy, warmer or cooler as compared to adjacent tissue.
- Subject's DTI has been discovered ≤ 72 hours after causative event
- Causative event of DTI is identified.
- Subject's index DTI is located on torso or body extremities.
- Subject is currently admitted to the hospital.
- Subject is able to be maneuvered into a position that is acceptable for MIST treatment.
- Subject's DTI presents with no clinical signs of acute infection.
- Subject or subject's legally authorized representative understands the nature of the procedures and provides written informed consent prior to study enrollment.
You may not qualify if…
- Subject's primary wound is a Stage I, Stage II, Stage III or Stage IV pressure ulcer.
- Subject's wound presents with a malignancy in the wound bed.
- Subject has a history of pressure ulcer / DTI in same location.
- Subject's DTI would require ultrasound near an electronic implant or prosthesis, e.g., near or over the heart, or over the thoracic area if the patient is using a cardiac pacemaker.
- Female subjects that are pregnant or refuse to utilize adequate contraceptive methods and are of childbearing age during the trial.
- Subject is terminally ill, defined as unable to survive beyond 14 days.
- Subject is known to be suffering from a disorder or other situation that the subject or investigator feels would interfere with compliance or other study requirements.
- Subject is currently enrolled or has been enrolled in the last 30 days in another device or drug trial.
Where it is running
- University of Nebraska Medical Center — Omaha, Nebraska, United States
Full record on ClinicalTrials.gov
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