Back to resultsSafety Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds
Primary Purpose
Burn Wound
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-Irradiance Monochromatic Biostimulation (LIMB) Device
Standard of Care
Sponsored by
About this trial
This is an interventional device feasibility trial for Burn Wound focused on measuring acute burn, thermal injury, wound, phototherapy, wound healing, antimicrobial
Eligibility Criteria
Inclusion Criteria:
- Patients receiving care at Shriners Hospitals for Children-Boston for a skin tissue injury.
- Patients who have at least one wound with exposed area sufficient, in the Investigator's opinion, to receive LIMB therapy.
- Willing and able to adhere to daily LIMB therapy protocol.
Exclusion Criteria:
- Patients deemed not medically stable by the treating Investigator.
- Patients with clinical signs and symptoms of systemic infection at baseline.
- Patients with burn wounds limited to their head and genitalia.
- Patients who, in the opinion of the Investigator, will not require daily dressing changes.
- Patients receiving photosensitizing agents that result in cutaneous phototoxicity prior to enrollment. Patients who have received one or more of the following photosensitizers cannot be enrolled into the study: photofrin, amiodarone, chloropromazine, fluoroquinolone antibiotics, thiazide diuretics, quinine, demethylchlortetracycline, psoralens, nalidixic acid, tetracycline, naproxen.
- Patients currently enrolled or participating in another investigational device, drug or biological trial within 30 days of the Screening Visit.
- Patients currently receiving any bandages or devices containing silver compounds.
- Patients on a ventilator, who have fluid resuscitation or are in any terminal condition.
Sites / Locations
- Shriners Hospitals for Children-BostonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
LIMB Phototherapy with SOC
LIMB Phototherapy without SOC
Arm Description
Arm I: The first 3 participants enrolled will receive standard of care therapy under the Low-Irradiance Monochromatic Biostimulation (LIMB) phototherapy device.
Arm II: The subsequent participants will receive only the Low-Irradiance Monochromatic Biostimulation (LIMB) phototherapy device without standard of care.
Outcomes
Primary Outcome Measures
Occurrence of Adverse Events from LIMB Phototherapy as Assessed by CTCAE v4.0
To evaluate the occurrence of adverse events (treatment-related or otherwise) from LIMB phototherapy from the time of device application up to 7 days. Reporting consistent with CTCAE v4.0. Duration of LIMB phototherapy can be shortened per discretion of treating Investigator.
Secondary Outcome Measures
Change in Bioburden assessed through Wound Culture
To evaluate the effect of LIMB phototherapy on microbial bioburden. Wound culture specimens are collected at each daily dressing change to measure the change in microbial bioburden when compared to baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03948360
Brief Title
Safety Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds
Official Title
A First-In-Human Pilot Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 7, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (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
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The primary purpose of this first-in-human, early feasibility study is to assess safety and feasibility of the Low-Irradiance Monochromatic Biostimulation (LIMB) System as a phototherapeutic intervention for the management of acute burn wounds. The prototype LIMB device will be evaluated for the occurrence of adverse events (treatment-related or otherwise) of the LIMB System, a portable, wearable, light-emitting system developed by Rogers Sciences, Inc. (RSI). The device will be administered in the small feasibility pilot to confirm design, usability and operating specifications that will inform procedures and endpoints of a subsequent large, multicenter clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Wound
Keywords
acute burn, thermal injury, wound, phototherapy, wound healing, antimicrobial
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
The study model is sequential. Arm I will consist of the first 3 participants, with each participant receiving LIMB phototherapy over standard of care (SOC). The subsequent participants will comprise Arm II, with each participant to receive only LIMB phototherapy without standard of care. Dose modifications of the phototherapy can be made in Arm II, and will be determined based on any treatment-related adverse events observed in Arm I. Up to 12 participants in total will be enrolled.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LIMB Phototherapy with SOC
Arm Type
Experimental
Arm Description
Arm I: The first 3 participants enrolled will receive standard of care therapy under the Low-Irradiance Monochromatic Biostimulation (LIMB) phototherapy device.
Arm Title
LIMB Phototherapy without SOC
Arm Type
Experimental
Arm Description
Arm II: The subsequent participants will receive only the Low-Irradiance Monochromatic Biostimulation (LIMB) phototherapy device without standard of care.
Intervention Type
Device
Intervention Name(s)
Low-Irradiance Monochromatic Biostimulation (LIMB) Device
Intervention Description
The LIMB System is a portable and wearable phototherapeutic system that consists of a Light Patch and Power Pack. The Power Pack delivers power to the Light Patch, which attaches to the participant and emits blue spectrum (405nm low-irradiance) light. The Light Patch contains an array of thin optical arrays that evenly illuminate the surface. The Power Pack is powered by a Lithium Thionyl Chloride (Li-SOCI2) battery.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of care therapy as defined for this clinical trial is standard gauze dressing soaked in Sulfamylon (mafenide acetate) solution.
Primary Outcome Measure Information:
Title
Occurrence of Adverse Events from LIMB Phototherapy as Assessed by CTCAE v4.0
Description
To evaluate the occurrence of adverse events (treatment-related or otherwise) from LIMB phototherapy from the time of device application up to 7 days. Reporting consistent with CTCAE v4.0. Duration of LIMB phototherapy can be shortened per discretion of treating Investigator.
Time Frame
up to 7 days
Secondary Outcome Measure Information:
Title
Change in Bioburden assessed through Wound Culture
Description
To evaluate the effect of LIMB phototherapy on microbial bioburden. Wound culture specimens are collected at each daily dressing change to measure the change in microbial bioburden when compared to baseline.
Time Frame
up to 7 days
Other Pre-specified Outcome Measures:
Title
Change in Pain as Assessed by Checklist Pain Behavior Scale
Description
To evaluate the change in participant's pain score during LIMB phototherapy treatment. Pain assessments taken daily at dressing change.
Time Frame
up to 7 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients receiving care at Shriners Hospitals for Children-Boston for a skin tissue injury.
Patients who have at least one wound with exposed area sufficient, in the Investigator's opinion, to receive LIMB therapy.
Willing and able to adhere to daily LIMB therapy protocol.
Exclusion Criteria:
Patients deemed not medically stable by the treating Investigator.
Patients with clinical signs and symptoms of systemic infection at baseline.
Patients with burn wounds limited to their head and genitalia.
Patients who, in the opinion of the Investigator, will not require daily dressing changes.
Patients receiving photosensitizing agents that result in cutaneous phototoxicity prior to enrollment. Patients who have received one or more of the following photosensitizers cannot be enrolled into the study: photofrin, amiodarone, chloropromazine, fluoroquinolone antibiotics, thiazide diuretics, quinine, demethylchlortetracycline, psoralens, nalidixic acid, tetracycline, naproxen.
Patients currently enrolled or participating in another investigational device, drug or biological trial within 30 days of the Screening Visit.
Patients currently receiving any bandages or devices containing silver compounds.
Patients on a ventilator, who have fluid resuscitation or are in any terminal condition.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L. Sheridan, MD
Organizational Affiliation
Shriners Hospitals for Children-Boston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shriners Hospitals for Children-Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert L Sheridan, MD
Phone
617-722-3000
Email
rsheridan@partners.org
12. IPD Sharing Statement
Learn more about this trial
Safety Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds
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