Deep Tissue Injury Treatment With MIST Therapy Versus Standard Care: REVERSE DTI Study

Multi-Center Study of the Effects of MIST Therapy on the Treatment of Deep Tissue Injury

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.

Study Overview

• Status: Terminated
• Conditions: Wound of Skin
• Intervention / Treatment: Other: Standard of Care; Device: MIST Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SOC - Standard of Care; Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed	Other: Standard of Care; Standard of Care consists of pressure relief, wound cleansing and dressing as needed
Active Comparator: MIST Therapy with SOC; Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days	Device: MIST Therapy; FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area.; Other Names: MIST Therapy, MIST, Non-Contact Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness	To compare between the treatment groups the effect of the assigned study treatment on the rate of progression of DTI to advanced stage pressure ulcer (Stage III or greater, continued DTI, or a pressure ulcer that is unable to be staged due to necrotic tissue). Stage I - Intact skin with non-blanchable redness of a localized area Stage II - Partial thickness loss of dermis Stage III - Full thickness loss, subcutaneous fat may be visible Stage IV - Full thickness tissue loss with exposed bone, tendon or muscle Unstageable - Full thickness tissue loss in which the base of the ulcer is covered by slough or eschar Continues deep tissue injury - purple or maroon localize area of discolored intact skin that may be mushy or boggy	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Wound Area	Measured from randomization to last visit (14 days or at discharge from hospital)	14 days

Collaborators and Investigators

• Sponsor: Celleration, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: February 20, 2012
• First Submitted That Met QC Criteria: February 23, 2012
• First Posted (Estimate): February 29, 2012

Study Record Updates

• Last Update Posted (Estimate): January 15, 2015
• Last Update Submitted That Met QC Criteria: January 6, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: CR-86034