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

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ClinicalTrials.gov Identifier: NCT01540981
Recruitment Status : Terminated (Lack of enrollment)
First Posted : February 29, 2012
Results First Posted : December 15, 2014
Last Update Posted : January 15, 2015
Sponsor:
Information provided by (Responsible Party):
Celleration, Inc.

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.

Condition or disease Intervention/treatment Phase
Wound of Skin Device: MIST Therapy Other: Standard of Care Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multi-Center Study of the Effects of MIST Therapy on the Treatment of Deep Tissue Injury
Study Start Date : February 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Effectiveness [ Time Frame: 14 days ]

    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



Secondary Outcome Measures :
  1. Change in Mean Wound Area [ Time Frame: 14 days ]
    Measured from randomization to last visit (14 days or at discharge from hospital)



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540981


Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
Celleration, Inc.
Investigators
Principal Investigator: Joyce Black, PhD, RN University of Nebraska

Responsible Party: Celleration, Inc.
ClinicalTrials.gov Identifier: NCT01540981     History of Changes
Other Study ID Numbers: CR-86034
First Posted: February 29, 2012    Key Record Dates
Results First Posted: December 15, 2014
Last Update Posted: January 15, 2015
Last Verified: January 2015