Safety Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds

A First-In-Human Pilot Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds

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.

Study Overview

• Status: Unknown
• Conditions: Burn Wound
• Intervention / Treatment: Device: Low-Irradiance Monochromatic Biostimulation (LIMB) Device; Other: Standard of Care

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Shriners Hospitals for Children-Boston
      • Contact: Robert L Sheridan, MD; Phone Number: 617-722-3000; Email: rsheridan@partners.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LIMB Phototherapy with SOC; Arm I: The first 3 participants enrolled will receive standard of care therapy under the Low-Irradiance Monochromatic Biostimulation (LIMB) phototherapy device.	Device: Low-Irradiance Monochromatic Biostimulation (LIMB) Device; 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.; Other: Standard of Care; Standard of care therapy as defined for this clinical trial is standard gauze dressing soaked in Sulfamylon (mafenide acetate) solution.
EXPERIMENTAL: LIMB Phototherapy without SOC; Arm II: The subsequent participants will receive only the Low-Irradiance Monochromatic Biostimulation (LIMB) phototherapy device without standard of care.	Device: Low-Irradiance Monochromatic Biostimulation (LIMB) Device; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain as Assessed by Checklist Pain Behavior Scale	To evaluate the change in participant's pain score during LIMB phototherapy treatment. Pain assessments taken daily at dressing change.	up to 7 days

Collaborators and Investigators

• Sponsor: Rogers Sciences Inc.
• Investigators: Principal Investigator: Robert L. Sheridan, MD, Shriners Hospitals for Children-Boston

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 7, 2017
• Primary Completion (ANTICIPATED): December 31, 2019
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (ACTUAL): May 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: acute burn, thermal injury, wound, phototherapy, wound healing, antimicrobial
• Additional Relevant MeSH Terms: Burns; Wounds and Injuries
• Other Study ID Numbers: BOS1705

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No