Burns, Trauma, Venous Ulcers
Conditions
Keywords
Low-frequency ultrasound, Wound healing, Split thickness wound healing, Skin graft donor site healing
Brief summary
Subjects requiring skin grafting due to burns, trauma, or chronic venous ulcers with split thickness donor sites expected to be between 20 and 200 square cm will be consecutively screened for study eligibility. This study is a prospective, randomized, controlled trial evaluating effect of MIST Therapy on the healing of split thickness skin graft donor sites compared to standard care. Subjects meeting all eligibility criteria and providing appropriate written informed consent will be enrolled for study participation.
Detailed description
Enrolled subjects will be randomized to receive one of two treatment courses: a) MIST Therapy in conjunction with standard of care (SOC) (treatment group); or b)SOC alone (control group). On post-op day 1, subjects will undergo a baseline evaluation prior to initiating assigned study treatment, including: wound measurement, wound bed evaluation, description of periwound skin, measurement of type and quantity of exudation, wound clinical symptoms (pain, burning, itching), and digital photography. Subject will then receive assigned study treatment. SOC includes, but is not limited to, fluid resuscitation, pain medications, systemic antibiotics, control of bleeding, and standard dressings as appropriate for the moisture balance of the wound. SOC also includes providing a hydrocolloid border around the wound with a transparent film dressing over the donor site. No advanced or impregnated dressings are allowed during the study. No topical antibiotics or antibiotic dressings, topical antiseptics (silver, iodine, etc.,) or antimicrobials are allowed. The transparent film will be removed each day and wound fluid will be collected for analysis. After wound fluid collection, subjects will receive their assigned study treatment. Subjects randomized to receive MIST Therapy will be treated daily for 5 consecutive days. Following administration of the assigned study treatment, subjects will have replacement of the transparent film. The hydrocolloid will remain in place on the border of intact skin. Evaluations performed will include a wound assessment, digital photography, wound pain assessment and an adverse event assessment. Following the initial 5 day treatment, the study wounds will be dressed per SOC with dressing changes as needed. Subjects will undergo a weekly wound assessment through 6 weeks from the date of study enrollment. A weekly wound assessment will include the assessment of maintained wound closure, digital photography, and an adverse event assessment.
Interventions
DEVICEMIST Therapy
Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment on a daily basis for 5 days.
OTHERStandard of care
Standard of care provided per site-specific protocol
Sponsors
Celleration, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subject of any race and at least 18 years old * Subject requires skin grafting * Subject's wound must be between 20 cm2 and 200 cm2 * Subject's wound presents with no clinical signs of acute infection * Subject has ahd no prior MIST Therapy to the enrolled wound * Subject or subject's legally authorized representative understands the nature of the procedure(s) and provides written informed consent prior to study enrollment * Subject is willing and able to comply with all specified care and visit requirements * Women of childbearing potential must not be pregnant or lactating, and must be using adequate and accepted contraceptive methods * Subject has a reasonable expectation of completing the study
Exclusion criteria
* Subject's condition requires the use of topical antibiotics at the time of study enrollment * Subject's wound would require ultrasound near an electronic implant or prosthesis, e.g., near or over the heart, or over the thoracic area if the subject is using a cardiac pacemaker * 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 investigational device or drug trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Wound Healing | Days to absence of drainage from the initial donor site harvest procedure | The primary endpoint is an average of the group for each participant's donor site wound closure time, defined as days to absence of drainage from the date of the initial donor site harvest procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Full Epithelialization | Days to full epithelialization | Time to full epithelialization in days from the date of initial donor site harvest procedure per the blinded adjudication of the donor site image. |
| Numeric Pain Score | 5 weeks | Average donor site pain score for each treatment group, numeric scale of 0 (no pain) to 10 (worst possible pain), at five weeks post skin graft procedure |
| Numeric Itching Score | 5 weeks | Average donor site itching score for treatment group, numeric scale 0 (no itch) to 10 (worst possible itch), at 5 weeks post skin graft procedure |
| Donor Site Recidivism Rate | 6 weeks | Number of donor sites that healed and then reopened during the study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MIST Therapy in Conjunction With Standard Care Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment
MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days. | 16 |
| Control Arm Standard of care treatment
Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | MIST Therapy in Conjunction With Standard Care | Control Arm | Total |
|---|---|---|---|
| Age, Continuous | 32 years | 54 years | 49 years |
| Baseline donor site size | 139.5 centimeters squared | 136.0 centimeters squared | 136.0 centimeters squared |
| BMI | 24.7 kilograms per meter squared | 25.0 kilograms per meter squared | 24.7 kilograms per meter squared |
| Number of donor sites | 2 number of sites | 1.5 number of sites | 2 number of sites |
| Race/Ethnicity, Customized African American | 4 participants | 3 participants | 7 participants |
| Race/Ethnicity, Customized Caucasian | 12 participants | 12 participants | 24 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 0 participants | 1 participants | 1 participants |
| Region of Enrollment United States | 16 participants | 16 participants | 32 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 16 | 4 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Rate of Wound Healing
The primary endpoint is an average of the group for each participant's donor site wound closure time, defined as days to absence of drainage from the date of the initial donor site harvest procedure.
Time frame: Days to absence of drainage from the initial donor site harvest procedure
Population: randomized participants that had a minimum of 4 out of 5 treatments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MIST Therapy in Conjunction With Standard Care | Rate of Wound Healing | 12.1 Days | Standard Deviation 6 |
| Control Arm | Rate of Wound Healing | 21.3 Days | Standard Deviation 14.7 |
Secondary
Donor Site Recidivism Rate
Number of donor sites that healed and then reopened during the study.
Time frame: 6 weeks
Population: Randomized subjects that had a minimum of 4 out of 5 study treatments and fully epithelialized during the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MIST Therapy in Conjunction With Standard Care | Donor Site Recidivism Rate | 1 participants that healed and reopened |
| Control Arm | Donor Site Recidivism Rate | 5 participants that healed and reopened |
Secondary
Numeric Itching Score
Average donor site itching score for treatment group, numeric scale 0 (no itch) to 10 (worst possible itch), at 5 weeks post skin graft procedure
Time frame: 5 weeks
Population: Randomized subjects with a minimum of 4 out of 5 study treatments and itching score reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MIST Therapy in Conjunction With Standard Care | Numeric Itching Score | 0.7 units on a scale | Standard Error 1.3 |
| Control Arm | Numeric Itching Score | 4.1 units on a scale | Standard Error 1.3 |
Secondary
Numeric Pain Score
Average donor site pain score for each treatment group, numeric scale of 0 (no pain) to 10 (worst possible pain), at five weeks post skin graft procedure
Time frame: 5 weeks
Population: randomized subjects that had a minimum of 4 out of 5 study treatments and with a numeric pain score reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MIST Therapy in Conjunction With Standard Care | Numeric Pain Score | 0 units on a scale | Standard Error 0.964 |
| Control Arm | Numeric Pain Score | 1.8 units on a scale | Standard Error 0.964 |
Secondary
Time to Full Epithelialization
Time to full epithelialization in days from the date of initial donor site harvest procedure per the blinded adjudication of the donor site image.
Time frame: Days to full epithelialization
Population: randomized subjects that had a minimum of 4 out of 5 study treatments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MIST Therapy in Conjunction With Standard Care | Time to Full Epithelialization | 18.2 days | Standard Deviation 8.8 |
| Control Arm | Time to Full Epithelialization | 27.5 days | Standard Deviation 12.2 |