NCT04011306

A Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns

A Multicenter, Prospective, Randomized, Comparative Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Rogers Sciences Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this feasibility study is to evaluate safety and effectiveness in healing outcomes of patients treated with Lumina24TM BLU (treatment), a Continuous Low-Irradiance Phototherapy (CLIP) device, as compared to standard of care (SOC) therapy (control) for the treatment of acute burns.

Detailed description

This feasibility study will consist of up to 15 subjects (Cohort I: up to 10 subjects with partial thickness second-degree burns; Cohort II: up to 5 subjects with deep partial thickness second- and/or full thickness third-degree burns). Each subject will be randomized to receive standard of care dressing on approximately half of the study burn site, and Lumina24TM BLU treatment on the remaining half of the study burn site. If the subject has bilaterally symmetric burns, they will be randomized to receive SOC or Lumina24TM BLU at the distinct anatomical burn locations (e.g. right/left thigh, right/left shoulder, etc.). The proposed feasibility study will inform critical primary and secondary outcome measures and procedural improvements necessary for a pivotal clinical study that would demonstrate both antimicrobial effectiveness and improved wound healing of acute burn wounds.

Conditions

• Burn Wound

Interventions

Type	Name	Description
DEVICE	Lumina24 BLU	Lumina24 BLU is the technology used to deliver continuous low-irradiance phototherapy for the treatment of acute burns

Timeline

• Start date: 2020-02-01
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2019-07-08
• Last updated: 2020-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study