Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
NCT ID:
NCT05796492
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05796492
Study Brief:
Protocol Section:
NCT05796492