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

NCT01540981 | Terminated Results DMC

• 1 other identifier: CR-86034
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound of Skin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Mean Wound Area

  14 days

Study Arms (2)

SOC - Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care

MIST Therapy with SOC

ACTIVE COMPARATOR

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

Interventions

MIST Therapy DEVICE

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

Also known as: MIST Therapy, MIST, Non-Contact Ultrasound

MIST Therapy with SOC

Standard of Care OTHER

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

SOC - Standard of Care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Celleration, Inc.: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Follow-up limited by discharge from hospital.

Results Point of Contact

• Title: Joyce Black
• Organization: UNMC

jblack@unmc.edu

(402) 559-6573

Study Officials

• Joyce Black, PhD, RN

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2012
• First Posted: February 29, 2012
• Study Start: February 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 15, 2015
• Results First Posted: December 15, 2014

Record last verified: 2015-01

Locations

US (1)