- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04011306
A Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns
January 12, 2020 updated by: Rogers Sciences Inc.
A Multicenter, Prospective, Randomized, Comparative Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns
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.
Study Overview
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
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida
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Contact:
- David W. Mozingo, MD
- Phone Number: 352-273-5670
- Email: david.mozingo@surgery.ufl.edu
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Lumina24 BLU is the technology used to deliver continuous low-irradiance phototherapy for the treatment of acute burns
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound Healing
Time Frame: up to 28 days
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Percentage area reduction (PAR) of the acute burn wound (SOC control site vs. Lumina24TM BLU treatment site)
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up to 28 days
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Number of adverse events
Time Frame: up to 28 days
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Safety measured by incidence of product-related AEs, SAEs, and UADEs
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up to 28 days
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Microbial load counts (Cohort II only)
Time Frame: up to 28 days
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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
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up to 28 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to healing
Time Frame: 12 months
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Time to burn wound healing at end of inpatient treatment
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12 months
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Numerical Pain Rating Scale
Time Frame: 12 months
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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)
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12 months
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Cost-effectiveness
Time Frame: 12 months
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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)
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12 months
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Patient and Observer Scar Assessment Scale
Time Frame: 12 months
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Difference in healing of hypertrophic scarring between SOC control site and Lumina24TM BLU treatment site assessed by Patient and Observer Scar Assessment Scale
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David W. Mozingo, MD, University of Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2020
Primary Completion (Anticipated)
August 1, 2021
Study Completion (Anticipated)
August 1, 2021
Study Registration Dates
First Submitted
June 28, 2019
First Submitted That Met QC Criteria
July 3, 2019
First Posted (Actual)
July 8, 2019
Study Record Updates
Last Update Posted (Actual)
January 14, 2020
Last Update Submitted That Met QC Criteria
January 12, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEP-06-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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