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

NCT ID: NCT04011306

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-29
• Study Completion Date: 2021-08-31

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.

Conditions

Burn Wound

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lumina24 BLU

Intervention Type: DEVICE

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

Interventions

Lumina24 BLU

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rogers Sciences Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David W. Mozingo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Facility Contacts

David W. Mozingo, MD

Role: primary

david.mozingo@surgery.ufl.edu

352-273-5670

Other Identifiers

CEP-06-001

Identifier Type: -

Identifier Source: org_study_id