A Multicenter, Prospective, Randomized, Comparative Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Wound Healing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females age > 18 to < 65
- •BMI > 20 kg/m2
- •Patients anticipated to receive inpatient care for a minimum of 72 hours at the respective medical facility for partial thickness second-degree, deep partial thickness second-degree and/or full thickness third-degree burn wounds.
- •Patients who have a > 5% to < 50% Total Body Surface Area (TBSA) wound.
- •Patients are willing and able to adhere to the therapy and protocol.
- •Female of childbearing potential must be willing to use acceptable methods of contraception.
- •Patients may or may not have clinical signs and symptoms of burn site infection at baseline.
- •Subject has read, understood and signed the approved ICF before screening procedures either by the patient or their legally authorized representative.
排除标准
- •Subjects with burns > third-degree (i.e. involvement of deeper tissues, such as muscle, tendons, or bone)
- •Patients deemed not medically stable by the treating Investigator.
- •Patients with burn wounds limited to their head or genitalia.
- •Patients currently enrolled or participating in another investigational device, drug or biological trial that would interfere with the Lumina24TM application.
- •Patients with inhalation burns.
- •Patients who are clinically septic.
- •Patients are pregnant.
- •Patients on a ventilator, who are undergoing acute fluid resuscitation, are hemodynamically unstable or are deemed 'comfort measures only'.
- •In the opinion of treating physician, patient not expected to survive beyond 30 days.
- •Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test at screening or baseline.
- •Known history of HIV infection, or active Hepatitis B or Hepatitis C infection.
- •Cancer requiring chemotherapy or radiation within previous 6 months or resection within the last 5 years (other than basal cell carcinoma.
- •Known chronic renal failure (serum creatine > 2 mg/dL) or chronic liver disease.
- •Pre-existing medical condition requiring current use of immunosuppressive medication or systemic steroids
- •Pre-existing medical conditions that would interfere with wound healing (i.e. diabetic patients with Hemoglobin A1c test result > 8%, malignancy, autoimmune disease)
- •Subjects with psychiatric conditions that are anticipated to result in protocol noncompliance
- •Chronic illicit drug or alcohol abuse that is anticipated to interfere with patient compliance with the protocol
- •Subject is incarcerated at the time of screening.
结局指标
主要结局
Wound Healing
时间窗: up to 28 days
Percentage area reduction (PAR) of the acute burn wound (SOC control site vs. Lumina24TM BLU treatment site)
Number of adverse events
时间窗: up to 28 days
Safety measured by incidence of product-related AEs, SAEs, and UADEs
Microbial load counts (Cohort II only)
时间窗: up to 28 days
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
次要结局
- Time to healing(12 months)
- Numerical Pain Rating Scale(12 months)
- Cost-effectiveness(12 months)
- Patient and Observer Scar Assessment Scale(12 months)