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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIST Therapy in conjunction with SOC | Experimental | Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment |
|
| Control arm | Active Comparator | Standard of care treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIST Therapy | Device | Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment on a daily basis for 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days to absence of drainage from the initial donor site harvest procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days to full epithelialization |
| Numeric Pain Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa J Gould, M.D.,Ph.D | James A. Haley Veterans Hospital | Principal Investigator |
| David Smith, MD | University South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38837237 | Derived | Sinha S, Gabriel VA, Arora RK, Shin W, Scott J, Bharadia SK, Verly M, Rahmani WM, Nickerson DA, Fraulin FO, Chatterjee P, Ahuja RB, Biernaskie JA. Interventions for postburn pruritus. Cochrane Database Syst Rev. 2024 Jun 5;6(6):CD013468. doi: 10.1002/14651858.CD013468.pub2. | |
| 25868409 | Derived | Prather JL, Tummel EK, Patel AB, Smith DJ, Gould LJ. Prospective Randomized Controlled Trial Comparing the Effects of Noncontact Low-Frequency Ultrasound with Standard Care in Healing Split-Thickness Donor Sites. J Am Coll Surg. 2015 Aug;221(2):309-18. doi: 10.1016/j.jamcollsurg.2015.02.031. Epub 2015 Mar 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | randomized participants that had a minimum of 4 out of 5 treatments | Posted | Mean | Standard Deviation | Days | Days to absence of drainage from the initial donor site harvest procedure |
|
6 weeks post skin graft procedure
Device related events and infections
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment | Infection of the donor site wound |
Participants were not blinded to study treatment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lisa Gould | University South Florida | (410) 736-4646 | lgould44@hotmail.com |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D014947 | Wounds and Injuries |
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard of care | Other | Standard of care provided per site-specific protocol |
|
|
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
| 5 weeks |
| 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 | 5 weeks |
| Donor Site Recidivism Rate | Number of donor sites that healed and then reopened during the study. | 6 weeks |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Median | Full Range | kilograms per meter squared |
|
| Number of donor sites | Median | Full Range | number of sites |
|
| Baseline donor site size | Median | Full Range | centimeters squared |
|
| OG001 | 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 |
|
|
| 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. | randomized subjects that had a minimum of 4 out of 5 study treatments | Posted | Mean | Standard Deviation | days | Days to full epithelialization |
|
|
|
| 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 | randomized subjects that had a minimum of 4 out of 5 study treatments and with a numeric pain score reported | Posted | Mean | Standard Error | units on a scale | 5 weeks |
|
|
|
| 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 | Randomized subjects with a minimum of 4 out of 5 study treatments and itching score reported | Posted | Mean | Standard Error | units on a scale | 5 weeks |
|
|
|
| Secondary | Donor Site Recidivism Rate | Number of donor sites that healed and then reopened during the study. | Randomized subjects that had a minimum of 4 out of 5 study treatments and fully epithelialized during the study. | Posted | Number | participants that healed and reopened | 6 weeks |
|
|
|
| 0 |
| 16 |
| 4 |
| 16 |
| EG001 | 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 | 0 | 16 | 4 | 16 |
|
| Discomfort | General disorders | Systematic Assessment | Discomfort with repositioning / treatment |
|
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| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |