The Study on Bacterial Load Following Open-to-air Management in Burn Patients.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The bacterial load at baseline for each treatment
研究概览
简要总结
Burns are one of the common forms of trauma and are a cause of unintentional death and injury. Management of burns becomes complex due to multiple associated complications, for instance, secondary infection of burn wounds is the most common complication associated with burn injuries. Treatment of bacterial infections with antibiotics is becoming more challenging due to the development of multidrug-resistance. Hence, there is a critical need to investigate and establish non-antibiotic approaches to prevent colonization, control growth, and eliminate bacteria from burn wounds. Recent studies have explored the beneficial effects of open-to-air strategies on wound healing. Based on the evidence, the investigators hypothesize that bacterial load in burn wounds will be lowered when treated with an open-to-air strategy compared to the traditional closed wound approach.
详细描述
Burns are one of the common forms of trauma and are a cause of unintentional death and injury in the world as well as in the United States (US). Management of burns becomes complex due to multiple associated complications, which result in short-term and long-term disability. Secondary infection of burn wounds is the most common complication associated with burn injuries. Approximately 10,000 people die in the US due to burn-related infections. For instance, gram-negative Pseudomonas aeruginosa is an opportunistic organism commonly found in burn wounds. Bacterial infections cause prolonged hospital stay, increase morbidity, and mortality of burn patients. Treatment of bacterial infections with antibiotics is becoming more challenging due to the development of multidrug-resistance. Hence, current antibiotic regimens and wound care are not always successful in eliminating bacterial infections. As such, there is a critical need to investigate and establish non-antibiotic approaches to prevent colonization, control growth, and eliminate bacteria from burn wounds.
Recent studies have explored the beneficial effects of open-to-air strategies on wound healing, especially in the presence of necrotizing infections. In an open-to air strategy, the wound is left open to the external environment with a heat lamp placed at 6 feet to promote drying. However, the spritz of a topical solution will be applied to avoid excessive drying. Based on current evidence, the investigators hypothesize that bacterial load in burn wounds will be lowered when treated with an open-to-air strategy compared to the traditional closed wound approach.
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
- 18 Years 至 89 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 89
- •Burn patients with TBSA≥ 20%
- •Any suspicion of skin colonization or infection based on a positive result of microbiologic testing. Testing would only be performed if the attending surgeon treating the patient had a clinical suspicion of wound infection.
排除标准
- •1. Children
研究组 & 干预措施
The experimental group
The experimental group will consist of wounds treated with the open-to-air strategy.
干预措施: Open-to-air strategy (Procedure)
The control group
The control group will consist of wounds treated with traditional closed-wound management with dressings soaked in topical antimicrobial solutions.
干预措施: Traditional closed-wound management (Procedure)
结局指标
主要结局
The bacterial load at baseline for each treatment
时间窗: At baseline
Scrapings of the superficial wound exudate and debris will be obtained at baseline (i.e., the 0-time point before implementing any the tested wound care management option) from both wound sites of each patient. The colony-forming units (CFUs) will be enumerated and CFUs/g will be calculated for treatment and control.
The bacterial load on day 1 for each treatment
时间窗: On day 1
Scrapings of the superficial wound exudate and debris will be obtained on day 1 (about 24 hours after obtaining samples for baseline measurement) from both wound sites of each patient. The colony-forming units (CFUs) will be enumerated and CFUs/g will be calculated for treatment and control.
The bacterial load on day 2 for each treatment
时间窗: On day 2
Scrapings of the superficial wound exudate and debris will be obtained on day 2 (about 48 hours after obtaining samples for baseline measurement) from both wound sites of each patient. The colony-forming units (CFUs) will be enumerated and CFUs/g will be calculated for treatment and control.
Difference in change in bacterial load for day 2
时间窗: Change in bacterial load from baseline and day 2
Change in bacterial load from baseline and day 2 and compared between treatment and control groups.
Difference in change in bacterial load for day 1
时间窗: Change in bacterial load from baseline and day 1
Change in bacterial load from baseline and day 1 and compared between treatment and control groups.
次要结局
- Prevalence of bacterial species on day 1 for each treatment(On day 2)
- Prevalence of bacterial species at baseline for each treatment(At baseline)
- Prevalence of bacterial species on day 1 for each treatment(On day 1)
