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

NCT03948360 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-05-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Rogers Sciences Inc.

    lead INDUSTRY

Principal Investigators

  • Robert L. Sheridan, MD · Shriners Hospitals for Children-Boston

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SEQUENTIAL

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-07
Primary Completion
2019-12-31
Completion
2019-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03948360 on ClinicalTrials.gov