NCT01540981

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Celleration, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-06-01
• Completion: 2013-07-01
• First posted: 2012-02-29
• Last updated: 2015-01-15
• Results posted: 2014-12-15

Locations

1 site across 1 country: United States