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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumina24 BLU | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumina24 BLU | Device | Lumina24 BLU is the technology used to deliver continuous low-irradiance phototherapy for the treatment of acute burns |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing | Percentage area reduction (PAR) of the acute burn wound (SOC control site vs. Lumina24TM BLU treatment site) | up to 28 days |
| Number of adverse events | Safety measured by incidence of product-related AEs, SAEs, and UADEs | up to 28 days |
| Microbial load counts (Cohort II only) | Difference of bioburden in/on the burn wound (SOC control site vs. Lumina24TM BLU treatment site) assessed by quantitative analysis of microbial load counts obtained from 3-mm punch biopsies and wound cultures | up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to healing | Time to burn wound healing at end of inpatient treatment | 12 months |
| Numerical Pain Rating Scale | Difference in pain related to acute burn wounds between SOC control site and Lumina24TM BLU treatment site assessed by patient-reported rating ranging from 0 to 10 (where 0 represents no pain and 10 represents worst possible pain) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David W. Mozingo, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| 12 months |
| Cost-effectiveness | Difference in cost-effectiveness of treatment regime between Lumina24TM BLU and SOC control assessed by difference in sum of costs associated with each treatment regime (including costs of OR visits required, inpatient stay, grafts and/or biologics used) | 12 months |
| Patient and Observer Scar Assessment Scale | Difference in healing of hypertrophic scarring between SOC control site and Lumina24TM BLU treatment site assessed by Patient and Observer Scar Assessment Scale | 12 months |