2nd Degree Burn of the Skin, Burn Wound
Conditions
Brief summary
This is a randomized, sham-controlled pilot study that will assess the safety and feasibility of splenic focused pulsed ultrasound treatment on burn wound healing time in 24 subjects (12 active ultrasound and 12 sham controls).
Detailed description
The Central Hypothesis underlying this study is that splenic ultrasound stimulation activates the splenic anti-inflammatory pathway, thereby producing reduction in circulating macrophage cytokine production, reduction of neutrophil invasiveness, or induction of phenotypic transition in circulating immune cells (e.g., M1 to M2 transition in macrophages) in patients with partial thickness wounds that cover \<20% body surface area. Approximately 24 subjects will participate in this study. Male and female subjects of all races and ethnicities will be recruited for study from the ethnically diverse patient population of the LAC+USC Burn Center from the surrounding area. Phase 0 Burn wound subjects will be screened and enrolled at the LAC+USC Burn Center located in Los Angeles, California. No other sites, neither regional nor outside of the United States are going to participate in enrollment of subjects. A General Electric LOGIQ E10 ultrasound machine with a C1-6-XD clear probe, will be used to selectively deliver pulsed ultrasound to the spleen. 12 months. 28 days or until healed (whichever comes first)
Interventions
DEVICEPulsed splenic ultrasound
A General Electric LOGIQ E10 ultrasound machine with a C1-6-XD clear probe, will be used to selectively deliver pulsed ultrasound to the spleen.
DEVICEUltrasound probe (no energy applied)
A General Electric LOGIQ E10 ultrasound probe will be placed over the spleen with no energy applied
Sponsors
General Electric Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or Female aged 18 or older * Second-degree burn wounds of less than 20% total body surface area (TBSA) * No active wound infection at screening based on clinical criteria * Able to provide written informed consent
Exclusion criteria
* Wounds determined by study clinicians to be ineligible, including those that may inhibit access to the spleen for the ultrasound procedure * Participating in another research study that may affect the conduct of results of this study * BMI \> 30 * Having or exhibiting any of the following: * Previous surgery of the spleen, esophagus, stomach, duodenum, or liver, including splenectomy * End stage renal disease and/or uremia * Active malignancy * Previous leukemia and/or lymphoma * Human immunodeficiency virus infection or AIDS * Rheumatoid arthritis or other immune-mediated diseases (e.g., inflammatory bowel disease * Arrythmias, including but not limited to, atrial fibrillation, atrial flutter, clinically significant bradycardia, ventricular arrhythmias, and A-V block * Implanted pacemaker or cardioverter/debribrillator * History of unstable angina, angioplasty or coronary arterial by-pass grafting surgery * History of stroke or TIA * Untreated thrombosis or bleeding disorders * Currently implanted vagus nerve stimulator * Currently implanted spinal cord stimulator or other chronically implanted electronic device * Receiving oral, topical, rectal, or parenteral corticosteroids in an unstable dose 4 weeks prior to baseline visit * Any immunosuppressive or cytotoxic medications * Clinically relevant history of alcohol or drug abuse as determined by the investigator including: * alcohol consumption within 4 days of the baseline visit * tobacco or nicotine product use within the past 1 month * recreational drug use within the past 1 month * Pregnant or breast feeding * Unable or unwilling to comply with study procedures * Have recently (within 3 months) been diagnosed with COVID, or have ever been diagnosed with long COVID * Have an autoimmune disorder, such as, rheumatoid arthritis or lupus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse device effects (ADEs) | Days 1 -28 | Review of anticipated device effects after splenic ultrasound insonification in subjects with partial thickness wounds that cover \<20% body surface area. |
| Median time to re-epithelialization using advanced digital imaging | 28 days or until healed (whichever comes first) | Re-epithelialization measured by digital planimetry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in groups in non-invasive perfusion measured visual analog scale, (VAS) | Days 7, 14, 21 and 28 | Doppler perfusion, scale 0-10 with 10 being worst outcome |
| Referral to scar management specialist | Days 7, 14, 21 and 28 | Scar management |
| Difference in groups in pain measured visual analog scale, (VAS) | Days 7, 14, 21 and 28 | Pain, scale 0-10 with 10 being worst outcome |
| Multiplexed analysis of plasma levels of inflammatory cytokines | Days 7, 14, 21 and 28 | Plasma levels of inflammatory cytokines, lab range values |
| Flow cytometry analysis of phenotype of macrophage, neutrophil, and T lymphocyte populations | Days 7, 14, 21 and 28 | Phenotype of macrophage, neutrophil, and T lymphocyte, lab range values |
| Scar assessments using Patient and Observer Scar Assessment Scale (POSAS) | Days 7, 14, 21 and 28 | A 5 point score ranging from 1 (normal pigmentation, no itching) to 5 (worst imaginable scar or sensation). |
| Difference in groups in itch measured visual analog scale, (VAS) | Days 7, 14, 21 and 28 | Itch, scale 0-10 with 10 being worst outcome |
Countries
United States
Outcome results
None listed