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

Wound of Skin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01540981
• Other study ID #: CR-86034
• Status: Terminated
• Phase: N/A
• First received: February 20, 2012
• Last updated: January 6, 2015
• Start date: February 2012
• Est. completion date: July 2013

Study information

• Verified date: January 2015
• Source: Celleration, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Wound of Skin

Intervention

Device:
• MIST Therapy
FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area.

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

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Celleration, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Mean Wound Area	Measured from randomization to last visit (14 days or at discharge from hospital)	14 days	No