Comparative study of negative pressure wound therapy versus conventional dressing for the management of traumatic wound
试验速览
- 阶段
- 1/2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1)Changes in wound size
研究概览
简要总结
the study of Comparative study of negative pressure wound therapy versus conventional dressing for the management of traumatic woundgoing to be conducted in trauma centre in IMS,BHU in which 100 patients will be recruited ,50 in each limb.Patients in Each group will be allocated by computer generated random allocation and each group will be assessed on every 5th day for the comparision. Comparision will be done on following points1) change in wound size. 2) percentage of the granulation tissue formed 3) change in the bacterial colony count.
End point of the study is to prepare the wound bed for either split thickness skin grafting or by primary closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
入排标准
- 年龄范围
- 10.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •patients giving consent for negative pressure therapy 2) clinically stable patients with traumatic wounds irrespective of mode or mechanism of trauma 3) patients of 10-70 years of age and either sex.
排除标准
- •refusal of consent 2) traumatic wounds with unmanaged underlying bony fracture 3) wounds with untreated underlying osteomyelitis 4) wounds with fistulas to organs or body cavity 5) severe anemia 6) wounds with associated malignancy 7) dry gangrene 8) patients with chronic conditions like:- a) uncontrolled diabetes mellitus b) peripheral vascular disease c) chronic venous insufficiency.
结局指标
主要结局
1)Changes in wound size
时间窗: Every 5 days
2)change in percentage of granulation tissue
时间窗: Every 5 days
3)change in bacteria colony count
时间窗: Every 5 days
次要结局
- 1) changes in blood counts(1 yr)