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

NCT04011306 | Unknown DMC FDA Device

• 1 other identifier: CEP-06-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn Wound

Outcome Measures

Primary Outcomes (3)

• Wound Healing

  Percentage area reduction (PAR) of the acute burn wound (SOC control site vs. Lumina24TM BLU treatment site)

  up to 28 days

• Number of adverse events

  Safety measured by incidence of product-related AEs, SAEs, and UADEs

  up to 28 days

• Microbial load counts (Cohort II only)

  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

  up to 28 days

Secondary Outcomes (4)

• Time to healing

  12 months

• Numerical Pain Rating Scale

  12 months

• Cost-effectiveness

  12 months

• Patient and Observer Scar Assessment Scale

  12 months

Study Arms (1)

Lumina24 BLU

EXPERIMENTAL

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.

Device: Lumina24 BLU

Interventions

Lumina24 BLU DEVICE

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

Lumina24 BLU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rogers Sciences Inc.: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• David W. Mozingo, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 8, 2019
• Study Start: February 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: January 14, 2020

Record last verified: 2020-01

Locations

US (1)