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临床试验/NCT03248154
NCT03248154撤回不适用

Burn Biofilm Infection in Adults and Children

Gayle Gordillo4 个研究点 分布在 1 个国家开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
4
主要终点
Detection of biofilm infection in burns

研究概览

简要总结

The objective of the study is to analyze the different implications (such as graft loss and conversion of indeterminate depth burns) of biofilm infections in burn patients. Additionally, it also aims at comparing children's resistance to biofilm infection at wound site than adults'. 300 subjects from 3 different age groups will be enrolled in 3 arms.

详细描述

Subjects will be recruited from three different age groups: 2-18 years old, 18-49 years old, and ≥ 50 years old. 150 patients will be enrolled in each age group for arms 1 and 2. Arm 3 consists of all patients enrolled in the study and involves drawing whole blood for analyzing cytokine response. Subjects will have at day 0, 3, 7, 14, 21, 28 +/- 2 days (as applicable until graft surgery occurs).At each study visit the following will be collected: burn wound data [Lund-Brower Chart, TBSA burn size, date of onset, length, width, area, depth of burn injury (as applicable), Standard of Care (SoC) treatment for burn] will be recorded, SoC labs since the onset of the burn wounds will be recorded (CBC w/ diff and glucose as applicable), digital imaging of the burn injury(s), Laser Doppler Imaging (LDI) will also be perfomed. Biopsies will be collected depending on the size of injury (4 from 2cm² burn size, to 10 from >8cm² burn size). Blister fluid will be collected by draining the fluid with a needle and syringe.Subjects in arm 2 will receive their Standard of Care (SoC) dressing prescribed by their provider or will receive the study dressing, 4x4 Procellera that will be applied to a specific area of the burn injury.

2 weeks after the grafting surgery, subjects will return for study visits at day 14, 21, 28 post-grafting where the following activities will be completed - burn wound data and medication review, digital image of the burn injury(s), LDI imaging, HUSD imaging, trans-epidermal water loss (TEWL) measurement. Whole blood will be collected.

Each subjects' medical chart will be followed for 3 months post completion of the study to identify patient outcomes (i.e. wound closure data, infection status/type, treatment status, surgical outcomes/complications - graft loss, patient death as applicable).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •(Aim 3 is included in all criteria):
  • •Aim 1 and 2:
  • •Ages 2 yrs. and older
  • •Thermal burns with 2-14% total body surface area (TBSA) injury
  • •Patients present within 3 days from the time of thermal burn injury
  • •Diagnosed by burn surgeon as having deep partial thickness or indeterminate depth burn (defined as uncertainty between deep second degree or third degree burns)
  • •Thermal burns with ≥20% TBSA

排除标准

  • •(Aim 3 is included in all criteria):
  • •Aim 1 and 2:
  • •Patients with chemical or electrical burns
  • •Pregnant women
  • •Patient/legal guardian/or next of kin unable to consent
  • •Immunosuppressed
  • •Taking immune modifying medications
  • •Patients requiring >72 hrs. hospital stay
  • •Harmonic Ultrasound & Doppler Imaging (HUSD) will be used to exclude burn wounds with thrombosed vessels at initial presentation

研究组 & 干预措施

Immunocompetent with 2-14% TBSA

No Intervention

Immunocompetent with 2-14% TBSA thermal burn subjects. Does biofilm infection result in conversion of partial-thickness burn wounds to full-thickness?

Immunocompromised with >=20% TBSA

Experimental

Immunocompromised patients with large thermal burn >=20% TBSA. Higher bacterial burden with biofilm infection will result in higher rates of graft loss. Does application of a wireless electroceutical dressing (Procellera) lower biofilm burden compared to burn subjects receiving standard of care therapy?

干预措施: Procellera (Device)

Peripheral blood - all subjects

No Intervention

All subjects enrolled in arms 1 and 2. Do children have a more robust innate immune response to prevent biofilm infection?

结局指标

主要结局

Detection of biofilm infection in burns

时间窗: 4 weeks

Tissue biopsies will be tested for presence of bacteria using SEM and culture.

次要结局

  • Assessing graft loss as a result of biofilm infection(4 weeks post grafting surgery)
  • Burn depth measurement(4 weeks)

研究者

发起方
Gayle Gordillo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gayle Gordillo

Associate Professor

Ohio State University

研究点 (4)

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