Advancing the Standard of Care for Pin Site Care: Prospective Single Center Study Using Medihoney HCS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Total Number of Pin Sites
研究概览
简要总结
The purpose of this study is to prospectively evaluate the effect of Active Leptospermum honey utilizing the MediHoney HCS dressing, on the occurrence of PIN site infections, and also to see if the use of MediHoney HCS reduces the frequency of dressing changes compared to published reports of routine standard pin site care.
详细描述
Up to 20 Diabetic Mellitus patients undergoing Open Reduction External Fixation (OREF) for foot and/or ankle fusions, fracture repair, or osteotomy will be enrolled to receive weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials. No procedures, tests or interventions will be performed exclusively for research purposes or more frequently than the standard of care. Upon completion of the study, pin sites sepsis rates will be compared to published reports for standard pin site care.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A signed and dated informed consent has been obtained from the subject.
- •Subject is able and willing to comply with study procedures.
- •Subject is 18 years of age or older.
- •Type I or II Diabetes
- •Albumin >2.5
- •A1C<12 or average fasting levels <200
- •ABI > .6 or biphasic pedal vessels by Doppler
- •Charcot arthropathy of lower extremity
- •Foot/ankle deformity
- •Foot/ankle fracture
- •Subject will undergo an Open Reduction with External Fixation (OREF).
排除标准
- •A1C > 12
- •ABI < .6 or monophasic pedal pulses on Doppler
- •Recent (<2 months) or ongoing bone infection based on radiograph or scan
- •Cellulitis of lower extremity within the last 2 months based on clinical exam and/or laboratory markers
- •Honey or honey based allergy
结局指标
主要结局
Total Number of Pin Sites
时间窗: Day of surgical intervention approximately 3hrs.
total number of pin sites for all patients enrolled
Number of Patients With Pin Site Infection
时间窗: weekly from baseline until frame removal, up to 16 weeks
Patients will be assessed weekly for pin site infection up until frame removal.
Change in Sepsis Rate
时间窗: weekly from baseline until frame removal, up to 16 weeks
Patients will be assessed weekly for sepsis or until frame is removed.
次要结局
未报告次要终点