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

NCT ID: NCT03948360

Last Updated: 2019-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-07
• Study Completion Date: 2019-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Low-Irradiance Monochromatic Biostimulation (LIMB) Device

Intervention Type: 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.

Standard of Care

Intervention Type: OTHER

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

LIMB Phototherapy without SOC

Arm II: The subsequent participants will receive only the Low-Irradiance Monochromatic Biostimulation (LIMB) phototherapy device without standard of care.

Group Type: EXPERIMENTAL

Low-Irradiance Monochromatic Biostimulation (LIMB) Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Standard of Care

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

Intervention Type: OTHER

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.

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rogers Sciences Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert L. Sheridan, MD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospitals for Children-Boston

Locations

Shriners Hospitals for Children-Boston

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Robert L Sheridan, MD

Role: primary

rsheridan@partners.org

617-722-3000

Other Identifiers

BOS1705

Identifier Type: -

Identifier Source: org_study_id