REVERSE Deep Tissue Injury (REVERSE DTI)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Celleration, Inc.
ClinicalTrials.gov Identifier:
NCT01540981
First received: February 20, 2012
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

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 Intervention
Wound of Skin
Device: MIST Therapy
Other: Standard of Care

Study Type: Interventional
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

Further study details as provided by Celleration, Inc.:

Primary Outcome Measures:
  • Effectiveness [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 130
Study Start Date: February 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Celleration, Inc.
ClinicalTrials.gov Identifier: NCT01540981     History of Changes
Other Study ID Numbers: CR-86034
Study First Received: February 20, 2012
Last Updated: March 5, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014