Clinical trial NCT01540981: Deep Tissue Injury Treatment With MIST Therapy Versus Standard Care: REVERSE DTI Study
Official title: Multi-Center Study of the Effects of MIST Therapy on the Treatment of Deep Tissue Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wound of Skin
Lead sponsor: Celleration, Inc.
Sponsor class: INDUSTRY
First posted: 2012-02-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Enrolled subjects will be randomized to receive one of two treatment courses: a) MIST Therapy in conjunction with Standard of Care (MIST + SOC) (treatment group) or b) SOC only (control group).

A randomized subject will be required to undergo a Baseline Evaluation. The Baseline Evaluation. A digital photo will be taken of the wound.

The subject will receive the assigned study treatment. Each subject will receive SOC wound care and off-loading daily throughout the study. Subjects will be treated daily for 5 days and then every other day until discharged or up to 14 days post enrollment.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Effectiveness
timeFrame: 14 days
Secondary outcomes:
measure: Change in Mean Wound Area
timeFrame: 14 days
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Joyce Black, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: