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

NCT03948360 | Unknown FDA Device

• 1 other identifier: BOS1705
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn Wound

Keywords

acute burn, thermal injury, wound, phototherapy, wound healing, antimicrobial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Bioburden assessed through Wound Culture

  up to 7 days

Other Outcomes (1)

• Change in Pain as Assessed by Checklist Pain Behavior Scale

  up to 7 days

Study Arms (2)

LIMB Phototherapy with SOC

EXPERIMENTAL

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; Other: Standard of Care

LIMB Phototherapy without SOC

EXPERIMENTAL

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

Interventions

Low-Irradiance Monochromatic Biostimulation (LIMB) Device 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.

LIMB Phototherapy with SOC; LIMB Phototherapy without SOC

Standard of Care OTHER

Standard of care therapy as defined for this clinical trial is standard gauze dressing soaked in Sulfamylon (mafenide acetate) solution.

LIMB Phototherapy with SOC

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rogers Sciences Inc.: lead

Study Sites (1)

Shriners Hospitals for Children-Boston

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Burns; Wounds and Injuries

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Robert L. Sheridan, MD

  Shriners Hospitals for Children-Boston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: May 13, 2019
• Study Start: September 7, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 13, 2019

Record last verified: 2019-05

Locations

US (1)