Status:
UNKNOWN
A Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns
Lead Sponsor:
Rogers Sciences Inc.
Conditions:
Burn Wound
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The primary purpose of this feasibility study is to evaluate safety and effectiveness in healing outcomes of patients treated with Lumina24TM BLU (treatment), a Continuous Low-Irradiance Phototherapy ...
Detailed Description
This feasibility study will consist of up to 15 subjects (Cohort I: up to 10 subjects with partial thickness second-degree burns; Cohort II: up to 5 subjects with deep partial thickness second- and/or...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04011306
Start Date
February 1 2020
End Date
August 1 2021
Last Update
January 14 2020
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610