NCT04063111Unknown不适用
ROLE OF VACUUM ASSISTED CLOSURE IN OPEN TYPE III B TIBIAL FRACTURES
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- - Time for definitive soft tissue coverage
研究概览
简要总结
- Evaluate the role of VAC in decreasing the time needed for soft tissue coverage and definitive fixation in open IIIB tibial fractures
详细描述
- Open fractures are injuries in which the skin and soft-tissue integument are disrupted and the underlying bone is exposed to the external environment. This communication results in contamination by microorganisms that can cause deep or superficial infection. Impaired vascularity, devitalized tissue, and loss of skeletal stability are all factors leading to increased susceptibility to infection after open fracture [1, 2].
- Current protocols for treating open fractures include early administration of antibiotics, timely surgical debridement, skeletal stabilization, sterile dressing, systemic support, and establishment of soft-tissue coverage in a wound environment that is clean [3, 4-8].
- VAC is being used to obviate the need for, or enhance the success of, free-flap coverage in open fractures that are significant enough to preclude primary closure, delayed primary closure, or healing by secondary intention. VAC device and its components, which in a closed system expose the open wound bed to negative pressure. This pressure removes edema or hemorrhage, mechanically pulls on the wound edges, decreases in wound surface area, improves circulation, and enhances proliferation of granulation tissue that filled the soft tissue defect, enhance debridement of wound debris, reducing the need for costly free-flap transfers. VAC devices have been used in many surgical disciplines but only recently have become popular in orthopedics [7, 9,].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Gustilo Type III B open fractures of the tibia [10].
- •Skeletal mature patients.
排除标准
- •- Bone defect more than 5 cm Gustilo Type III B open fractures of the tibia.
- •Medical commodities that make the patient unfit for surgery. (e.g. Liver Cell Failure, liver cirrhosis, renal failure )
研究组 & 干预措施
group B
Active Comparator
Group B will be treated with conventional dressing
干预措施: CONVENTIONAL DRESSING (Device)
group A
Active Comparator
Group A will be treated with vacuum assistant closure
干预措施: vacuum assistant closure (Device)
结局指标
主要结局
- Time for definitive soft tissue coverage
时间窗: baseline
- Evaluate the role of VAC in decreasing the time needed for soft tissue coverage and definitive fixation in open IIIB tibial fractures
次要结局
- - The type of soft tissue reconstruction(baseline)
研究者
Albair Malaka Sedki
Resident of orthopedic surgery department
Assiut University
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