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

NCT ID: NCT01540981

Last Updated: 2015-01-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-07-31

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.

Conditions

Wound of Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

SOC - Standard of Care

Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Standard of Care consists of pressure relief, wound cleansing and dressing as needed

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

Group Type: ACTIVE_COMPARATOR

MIST Therapy

Intervention Type: DEVICE

FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area.

Interventions

MIST Therapy

FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area.

Intervention Type: DEVICE

Standard of Care

Standard of Care consists of pressure relief, wound cleansing and dressing as needed

Intervention Type: OTHER

Other Intervention Names

MIST Therapy, MIST, Non-Contact Ultrasound

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celleration, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joyce Black, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

CR-86034

Identifier Type: -

Identifier Source: org_study_id