A Randomized, Double-Blind, Placebo-Controlled Study of the Effect of Cranberry Extract on the Incidence of Infections 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
- Overall Infection Rate
研究概览
简要总结
Bacterial infections are a common complication in patients suffering from burns. These infections can cause significant morbidity and often mortality. Antimicrobial resistance coupled with the prevalence of burn-related infections warrants the identification of alternative substances in the treatment of burn-related infections. The cranberry has been examined as a potential agent in the prevention of other types of infections and it appears to have anti-adherence effects on bacteria. In addition, the cranberry has demonstrated general inhibitory effects against some types of bacteria suggesting that it may be a useful agent in the prevention of bacterial infections in burn patients. The purpose of the present study is to investigate the effect of cranberry extract on the incidence of infections in burn patients.
详细描述
Methods
Design. The present study is a prospective, randomized, double-blind, placebo-controlled study of the effect of taking three times daily doses of cranberry extract in capsule form on the incidence of infection in burn patients.
Participants. Eighty patients suffering from burns and admitted to the Saint Elizabeth Regional Medical Center Burn Center, Lincoln, NE will take place in the proposed study.
Inclusion Criteria. Patients will be asked to participate in the study if the following criteria are met:
- Patients are admitted to the Saint Elizabeth Regional Medical Center Burn Unit.
- Age 19 and older.
- Patients have an expected hospital stay of 7 days or more.
- Patients are able to consume oral medication capsules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are admitted to the Saint Elizabeth Regional Medical Center Burn Unit.
- •Age 19 and older.
- •Patients have an expected hospital stay of 7 days or more.
- •Patients are able to consume oral medication capsules.
排除标准
- •Patients have a known infection.
- •Patients are not able to consume oral medication capsules.
- •Patients have any known allergies to cranberry or placebo components.
- •Patients have known allergy to aspirin (cranberries may contain salicylic acid).
- •Patients are pregnant or breast-feeding.
- •Patients are taking warfarin
- •Patients with known nephrolithiasis.
- •Patients with renal impairment as evidenced by a creatinine clearance that is less than predicted by Cockroft-Gault formula.
研究组 & 干预措施
Inert Placebo Capsule
干预措施: Inert Placebo Capsule (Drug)
Cranberry Extract
干预措施: Cranberry Extract (Dietary Supplement)
结局指标
主要结局
Overall Infection Rate
时间窗: average of 17 days
Patients will be enrolled in the study throughout the duration of their hospital stay. They will be assessed on a daily basis.
次要结局
- Time between study enrollment and acquisition of infection(average of 17 days)