Wound of Skin
Conditions
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.
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.
Interventions
DEVICEMIST Therapy
FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area.
OTHERStandard of Care
Standard of Care consists of pressure relief, wound cleansing and dressing as needed
Sponsors
Celleration, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Wound Area | 14 days | Measured from randomization to last visit (14 days or at discharge from hospital) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SOC - Standard of Care Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed
Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed | 5 |
| 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
MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area. | 6 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | MIST Therapy With SOC | Total | SOC - Standard of Care |
|---|---|---|---|
| Age, Continuous | 69.5 years | 65 years | 55 years |
| Age of Wound | 2.5 days | 3.0 days | 3.0 days |
| BMI | 27.7 kilograms per meter squared | 28.6 kilograms per meter squared | 28.6 kilograms per meter squared |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 11 Participants | 5 Participants |
| Region of Enrollment United States | 6 participants | 11 participants | 5 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 3 Participants |
| Type of Injury Leading to Suspected DTI Cardiac Arrest/Hemodynamic Crash | 0 participants | 1 participants | 1 participants |
| Type of Injury Leading to Suspected DTI Other | 1 participants | 3 participants | 2 participants |
| Type of Injury Leading to Suspected DTI Shearing | 0 participants | 1 participants | 1 participants |
| Type of Injury Leading to Suspected DTI Sustained Immobility | 5 participants | 6 participants | 1 participants |
| Wound Location Buttocks | 1 participants | 1 participants | 0 participants |
| Wound Location Heel | 2 participants | 3 participants | 1 participants |
| Wound Location Ischium | 1 participants | 1 participants | 0 participants |
| Wound Location Sacrum/Coccyx | 2 participants | 6 participants | 4 participants |
| Wound Size | 13.9 centimeters squared | 7.4 centimeters squared | 3.8 centimeters squared |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 6 |
| serious Total, serious adverse events | 0 / 5 | 0 / 6 |
Outcome results
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
Time frame: 14 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SOC - Standard of Care | Effectiveness | Healed | 0 participants |
| SOC - Standard of Care | Effectiveness | Pressure Ulcer Stage II | 1 participants |
| SOC - Standard of Care | Effectiveness | Unstageable | 0 participants |
| SOC - Standard of Care | Effectiveness | DTI | 4 participants |
| MIST Therapy With SOC | Effectiveness | DTI | 2 participants |
| MIST Therapy With SOC | Effectiveness | Healed | 1 participants |
| MIST Therapy With SOC | Effectiveness | Unstageable | 2 participants |
| MIST Therapy With SOC | Effectiveness | Pressure Ulcer Stage II | 1 participants |
Secondary
Change in Mean Wound Area
Measured from randomization to last visit (14 days or at discharge from hospital)
Time frame: 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOC - Standard of Care | Change in Mean Wound Area | 0.94 square centimeters | Standard Deviation 6.54 |
| MIST Therapy With SOC | Change in Mean Wound Area | -21.5 square centimeters | Standard Deviation 42.4 |