Clinical trial NCT03948360: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Burn Wound
Keywords: acute burn, thermal injury, wound, phototherapy, wound healing, antimicrobial
Lead sponsor: Rogers Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-13
Enrollment: 12
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: DEVICE_FEASIBILITY

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.


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.

Primary outcomes:
measure: Occurrence of Adverse Events from LIMB Phototherapy as Assessed by CTCAE v4.0
timeFrame: up to 7 days
Secondary outcomes:
measure: Change in Bioburden assessed through Wound Culture
timeFrame: up to 7 days
Other outcomes:
measure: Change in Pain as Assessed by Checklist Pain Behavior Scale
timeFrame: up to 7 days
Locations:
city: Boston
country: United States
facility: Shriners Hospitals for Children-Boston
state: Massachusetts
Study officials:
affiliation: Shriners Hospitals for Children-Boston
name: Robert L. Sheridan, MD
role: PRINCIPAL_INVESTIGATOR
References: