跳至主要内容
临床试验/NCT00582998
NCT00582998已完成不适用

Vacuum Assisted Closure as a Treatment for Soft Tissue Injuries Sustained as a Result of Calcaneus, Tibial Plateau and Pilon Fractures

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 249 人开始时间: 2001年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
249
试验地点
2
主要终点
Healing of Orthopaedic Trauma Extremity Wound Fractures (Calcaneus, Pilon and Tibial Plateau)

研究概览

简要总结

This project is designed as a prospective, randomized, comparative study evaluating the use of a negative pressure vacuum device in treating soft tissue injuries and the surgical incision following open reduction and internal fixation of calcaneus, tibial plateau, and pilon fractures.

详细描述

Patients who have a calcaneus fracture requiring open reduction and internal fixation through a lateral approach and who give informed consent to enter the study will be randomized into two groups. Randomization will be stratified for each of the three fracture types. Group A will be patients treated with daily dressing changes and wound evaluations beginning on post operative day 1. Group B patients will have a VAC device placed in the operating room, with the first post-operative wound evaluation taking place 48 hours post-op. If at the first post-operative evaluation there is marked drainage, the VAC device will be replaced with re-evaluation approximately 48 hours later.

The outcome variables consist of the number of days and amount of wound drainage, incidence of wound breakdown, incidence of flap coverage, incidence of infection, return to the operating room for repeat irrigation and debridement , the need for repeat wound closure, and any other intraoperative and postoperative complications recorded in medical record and on the study data collection form.

Patients who have a tibial plateau fracture requiring open reduction and internal fixation and who give informed consent to enter the study will be randomized into two groups. Group A will be patients treated with daily dressing changes and wound evaluations beginning on post operative day 2. Group B patients will have a VAC device placed in the operating room, with the first post-operative wound evaluation taking place 48 hours post-op. If at the first post-operative evaluation there is marked drainage the VAC device will be replaced with re-evaluation approximately 48 hours later. Patients with open tibial plateau fractures will be included in both groups A and B but will be sub-stratified within each group.

The outcome variables consist of the number of days and amount of wound drainage, incidence of wound breakdown, incidence of flap coverage, incidence of infection, return to the operating room for repeat irrigation and debridement , the need for repeat wound closure, and any other intraoperative and postoperative complications recorded in medical record and on the study data collection form.

Patients who have a pilon fracture requiring open reduction and internal fixation and who give informed consent to enter the study will be randomized into two groups. Group A will be patients treated with daily dressing changes and wound evaluations beginning on post operative day 2. Group B patients will have a VAC device placed in the operating room, with the first post-operative wound evaluation taking place 48 hours post-op. If at the first post-operative evaluation there is marked drainage the VAC device will be replaced with re-evaluation approximately 48 hours later. Patients with open pilon fractures will be included in both groups A and B but will be sub-stratified within each group.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have a closed calcaneus, tibial plateau or pilon fracture requiring open reduction and internal fixation.
  • Adult patients (19 years and older)

排除标准

  • No clinical evidence of infection
  • Patients unable or unwilling to give informed consent

研究组 & 干预措施

Standard Wound Dressing

Active Comparator

Standard post-operative wound dressing

干预措施: Standard Wound Dressing (Procedure)

Vacuum Assisted Closure Device

Active Comparator

Vacuum Assisted Closure (VAC) device

干预措施: Vacuum Assisted Closure Device (Device)

结局指标

主要结局

Healing of Orthopaedic Trauma Extremity Wound Fractures (Calcaneus, Pilon and Tibial Plateau)

时间窗: The time from injury from surgical stabilization (14 days)

Healing of Orthopaedic Trauma Extremity Wounds: Calcaneus, Pilon and Tibial Plateau Fractures with standard dressing versus negative pressure wound therapy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steven Theiss, MD

Primary Investigator

University of Alabama at Birmingham

研究点 (2)

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