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

Burn Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03948360
• Other study ID #: BOS1705
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2019
• Source: Rogers Sciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burn Wound
• Burns
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Shriners Hospitals for Children-Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Rogers Sciences Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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