Deep Tissue Injury Treatment With MIST Therapy Versus Standard Care: REVERSE DTI Study
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Multi-Center Study of the Effects of MIST Therapy on the Treatment of Deep Tissue Injury|
- Effectiveness [ Time Frame: 14 days ] [ Designated as safety issue: No ]
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
- Change in Mean Wound Area [ Time Frame: 14 days ] [ Designated as safety issue: No ]Measured from randomization to last visit (14 days or at discharge from hospital)
|Study Start Date:||February 2012|
|Study Completion Date:||July 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
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 Name: MIST Therapy, MIST, Non-Contact Ultrasound
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540981
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|Principal Investigator:||Joyce Black, PhD, RN||University of Nebraska|