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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011306
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Rogers Sciences Inc.

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.

Condition or disease Intervention/treatment Phase
Burn Wound Device: Lumina24 BLU Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized, Comparative Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
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.
Device: Lumina24 BLU
Lumina24 BLU is the technology used to deliver continuous low-irradiance phototherapy for the treatment of acute burns




Primary Outcome Measures :
  1. 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)

  2. Number of adverse events [ Time Frame: up to 28 days ]
    Safety measured by incidence of product-related AEs, SAEs, and UADEs

  3. 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


Secondary Outcome Measures :
  1. Time to healing [ Time Frame: 12 months ]
    Time to burn wound healing at end of inpatient treatment

  2. 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)

  3. 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)

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011306


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Contact: David W. Mozingo, MD    352-273-5670    david.mozingo@surgery.ufl.edu   
Sponsors and Collaborators
Rogers Sciences Inc.
Investigators
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Principal Investigator: David W. Mozingo, MD University of Florida
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Responsible Party: Rogers Sciences Inc.
ClinicalTrials.gov Identifier: NCT04011306    
Other Study ID Numbers: CEP-06-001
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020

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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
Additional relevant MeSH terms:
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Burns
Wounds and Injuries