Back to results

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

Primary Purpose

Burn Wound

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lumina24 BLU

About this trial

This is an interventional treatment trial for Burn Wound

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lumina24 BLU

Arm Description

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.

Outcomes

Primary Outcome Measures

Wound Healing

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

Number of adverse events

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

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

Secondary Outcome Measures

Time to healing

Time to burn wound healing at end of inpatient treatment

Numerical Pain Rating Scale

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

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

Difference in healing of hypertrophic scarring between SOC control site and Lumina24TM BLU treatment site assessed by Patient and Observer Scar Assessment Scale

Full Information

NCT ID

NCT04011306

First Posted

June 28, 2019

Last Updated

January 12, 2020

Sponsor

Rogers Sciences Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04011306

Brief Title

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

Official Title

A Multicenter, Prospective, Randomized, Comparative Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

February 2020 (Anticipated)

Primary Completion Date

August 2021 (Anticipated)

Study Completion Date

August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rogers Sciences Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burn Wound

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lumina24 BLU

Arm Type

Experimental

Arm Description

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 Type

Device

Intervention Name(s)

Lumina24 BLU

Intervention Description

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

Primary Outcome Measure Information:

Title

Wound Healing

Description

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

Time Frame

up to 28 days

Title

Number of adverse events

Description

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

Time Frame

up to 28 days

Title

Microbial load counts (Cohort II only)

Description

Time Frame

up to 28 days

Secondary Outcome Measure Information:

Title

Time to healing

Description

Time to burn wound healing at end of inpatient treatment

Time Frame

12 months

Title

Numerical Pain Rating Scale

Description

Time Frame

12 months

Title

Cost-effectiveness

Description

Time Frame

12 months

Title

Patient and Observer Scar Assessment Scale

Description

Difference in healing of hypertrophic scarring between SOC control site and Lumina24TM BLU treatment site assessed by Patient and Observer Scar Assessment Scale

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David W. Mozingo, MD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David W. Mozingo, MD

Phone

352-273-5670

david.mozingo@surgery.ufl.edu

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs