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

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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.

Tracking Information
First Submitted Date  ICMJE June 28, 2019
First Posted Date  ICMJE July 8, 2019
Last Update Posted Date January 14, 2020
Estimated Study Start Date  ICMJE February 2020
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Burn Wound
Intervention  ICMJE Device: Lumina24 BLU
Lumina24 BLU is the technology used to deliver continuous low-irradiance phototherapy for the treatment of acute burns
Study Arms  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 12, 2020)
15
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04011306
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Rogers Sciences Inc.
Study Sponsor  ICMJE Rogers Sciences Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David W. Mozingo, MD University of Florida
PRS Account Rogers Sciences Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP