A Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns

• ClinicalTrials.gov Identifier: NCT04011306
• Recruitment Status: Not yet recruiting
• First Posted: July 8, 2019
• Last Update Posted: January 14, 2020
• Sponsor: Rogers Sciences Inc.
• Information provided by (Responsible Party): Rogers Sciences Inc.

Tracking Information

• First Submitted Date: June 28, 2019
• First Posted Date: July 8, 2019
• Last Update Posted Date: January 14, 2020
• Estimated Study Start Date: February 2020
• Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 12, 2020)

• Wound Healing [ Time Frame: up to 28 days ]
  Percentage area reduction (PAR) of the acute burn wound (SOC control site vs. Lumina24TM BLU treatment site)
• Number of adverse events [ Time Frame: up to 28 days ]
  Safety measured by incidence of product-related AEs, SAEs, and UADEs
• Microbial load counts (Cohort II only) [ Time Frame: up to 28 days ]
  Difference of bioburden in/on the burn wound (SOC control site vs. Lumina24TM BLU treatment site) assessed by quantitative analysis of microbial load counts obtained from 3-mm punch biopsies and wound cultures

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: January 12, 2020)

• Time to healing [ Time Frame: 12 months ]
  Time to burn wound healing at end of inpatient treatment
• Numerical Pain Rating Scale [ Time Frame: 12 months ]
  Difference in pain related to acute burn wounds between SOC control site and Lumina24TM BLU treatment site assessed by patient-reported rating ranging from 0 to 10 (where 0 represents no pain and 10 represents worst possible pain)
• Cost-effectiveness [ Time Frame: 12 months ]
  Difference in cost-effectiveness of treatment regime between Lumina24TM BLU and SOC control assessed by difference in sum of costs associated with each treatment regime (including costs of OR visits required, inpatient stay, grafts and/or biologics used)
• Patient and Observer Scar Assessment Scale [ Time Frame: 12 months ]
  Difference in healing of hypertrophic scarring between SOC control site and Lumina24TM BLU treatment site assessed by Patient and Observer Scar Assessment Scale

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns
• Official Title: A Multicenter, Prospective, Randomized, Comparative Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns
• 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 (CLIP) device, as compared to standard of care (SOC) therapy (control) for the treatment of acute burns.
• 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 full thickness third-degree burns). Each subject will be randomized to receive standard of care dressing on approximately half of the study burn site, and Lumina24TM BLU treatment on the remaining half of the study burn site. If the subject has bilaterally symmetric burns, they will be randomized to receive SOC or Lumina24TM BLU at the distinct anatomical burn locations (e.g. right/left thigh, right/left shoulder, etc.). The proposed feasibility study will inform critical primary and secondary outcome measures and procedural improvements necessary for a pivotal clinical study that would demonstrate both antimicrobial effectiveness and improved wound healing of acute burn wounds.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Burn Wound

Intervention

Device: Lumina24 BLU

Lumina24 BLU is the technology used to deliver continuous low-irradiance phototherapy for the treatment of acute burns

Study Arms

Experimental: Lumina24 BLU

Each subject will be randomized to receive standard of care dressing on approximately half of the study burn site, and Lumina24TM BLU treatment on the remaining half of the study burn site.

Intervention: Device: Lumina24 BLU

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: January 12, 2020): 15
• Original Enrollment: Not Provided
• Estimated Study Completion Date: August 2021
• Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04011306
• Other Study ID Numbers: CEP-06-001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

• IPD Sharing Statement: Not Provided
• Responsible Party: Rogers Sciences Inc.
• Study Sponsor: Rogers Sciences Inc.
• Collaborators: Not Provided

Investigators

• Principal Investigator: David W. Mozingo, MD; University of Florida

• PRS Account: Rogers Sciences Inc.
• Verification Date: January 2020