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:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-26 @ 5:19 PM
NCT ID:
NCT04011306
Eligibility Criteria:
Inclusion Criteria:
* Males or females age \> 18 to \< 65
* BMI \> 20 kg/m2
* Patients anticipated to receive inpatient care for a minimum of 72 hours at the respective medical facility for partial thickness second-degree, deep partial thickness second-degree and/or full thickness third-degree burn wounds.
* Patients who have a \> 5% to \< 50% Total Body Surface Area (TBSA) wound.
* Patients are willing and able to adhere to the therapy and protocol.
* Female of childbearing potential must be willing to use acceptable methods of contraception.
* Patients may or may not have clinical signs and symptoms of burn site infection at baseline.
* Subject has read, understood and signed the approved ICF before screening procedures either by the patient or their legally authorized representative.
Exclusion Criteria:
* Subjects with burns \> third-degree (i.e. involvement of deeper tissues, such as muscle, tendons, or bone)
* Patients deemed not medically stable by the treating Investigator.
* Patients with burn wounds limited to their head or genitalia.
* Patients currently enrolled or participating in another investigational device, drug or biological trial that would interfere with the Lumina24TM application.
* Patients with inhalation burns.
* Patients who are clinically septic.
* Patients are pregnant.
* Patients on a ventilator, who are undergoing acute fluid resuscitation, are hemodynamically unstable or are deemed 'comfort measures only'.
* In the opinion of treating physician, patient not expected to survive beyond 30 days.
* Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test at screening or baseline.
* Known history of HIV infection, or active Hepatitis B or Hepatitis C infection.
* Cancer requiring chemotherapy or radiation within previous 6 months or resection within the last 5 years (other than basal cell carcinoma.
* Known chronic renal failure (serum creatine \> 2 mg/dL) or chronic liver disease.
* Pre-existing medical condition requiring current use of immunosuppressive medication or systemic steroids
* Pre-existing medical conditions that would interfere with wound healing (i.e. diabetic patients with Hemoglobin A1c test result \> 8%, malignancy, autoimmune disease)
* Subjects with psychiatric conditions that are anticipated to result in protocol noncompliance
* Chronic illicit drug or alcohol abuse that is anticipated to interfere with patient compliance with the protocol
* Subject is incarcerated at the time of screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04011306
Study Brief:
Protocol Section:
NCT04011306