Burn Wound Clinical Trial
— GE-MTECOfficial title:
Fieldable Ultrasound Treatment to Enhance Inflammatory-Proliferative Phase Transition and Reduce Wound Healing Time
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).
Status | Recruiting |
Enrollment | 24 |
Est. completion date | September 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | LAC+USC Medical Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
General Electric Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and severity of adverse device effects (ADEs) | Review of anticipated device effects after splenic ultrasound insonification in subjects with partial thickness wounds that cover <20% body surface area. | Days 1 -28 | |
Primary | Median time to re-epithelialization using advanced digital imaging | Re-epithelialization measured by digital planimetry | 28 days or until healed (whichever comes first) | |
Secondary | Difference in groups in pain measured visual analog scale, (VAS) | Pain, scale 0-10 with 10 being worst outcome | Days 7, 14, 21 and 28 | |
Secondary | Difference in groups in itch measured visual analog scale, (VAS) | Itch, scale 0-10 with 10 being worst outcome | Days 7, 14, 21 and 28 | |
Secondary | Difference in groups in non-invasive perfusion measured visual analog scale, (VAS) | Doppler perfusion, scale 0-10 with 10 being worst outcome | Days 7, 14, 21 and 28 | |
Secondary | Referral to scar management specialist | Scar management | Days 7, 14, 21 and 28 | |
Secondary | Scar assessments using Patient and Observer Scar Assessment Scale (POSAS) | A 5 point score ranging from 1 (normal pigmentation, no itching) to 5 (worst imaginable scar or sensation). | Days 7, 14, 21 and 28 | |
Secondary | Multiplexed analysis of plasma levels of inflammatory cytokines | Plasma levels of inflammatory cytokines, lab range values | Days 7, 14, 21 and 28 | |
Secondary | Flow cytometry analysis of phenotype of macrophage, neutrophil, and T lymphocyte populations | Phenotype of macrophage, neutrophil, and T lymphocyte, lab range values | Days 7, 14, 21 and 28 |
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