Vacuum Assisted Closure as a Treatment for Open Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Healing of Orthopaedic Trauma Open Fractures
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 traumatic wounds sustained associated with an open fracture.
详细描述
Soft tissue injury following an open fracture is a significant problem following surgical treatment of traumatic skeletal injuries. The soft tissue injury results from a combination of the initiating trauma and additional tissue injury during surgery. Current treatment includes open reduction and internal fixation versus external fixation, irrigation and debridement following admission, decreased activity (non weight bearing status on the injured extremity), maintaining the patient as an inpatient in the hospital, repeated irrigation and debridements (36-72 hours following the initial trauma) with concomitant wound culturing until which time it is determined that either delayed primary closure, or skin grafting with/without flap coverage should be attempted.
All patients in the study will be treated with the appropriate empiric antibiotic regimen until wound culture results justify modification for antibiotic sensitivity/resistance reasons. In general, barring patient allergy, the empiric antibiotic regimen will adhere to the Gustilo and Anderson classification as follows:
Grade I : Ancef Grade II : Ancef and Gentamicin or Zosyn Grade III : Ancef, Gentamicin or Zosyn, and add a Penicillin for grade IIIB open fractures.
All wounds will be assessed initially at admission following the Gustilo and Anderson classification for open fractures. Subsequent wound assessments in the operating room will be graded according to the following descriptive scale:
Type A wound: Abundant granulation tissue, ready for closure. Type B Wound: Granulation tissue present but inadequate for closure, Wound is clinically clean appearing. Type C Wound: No granulation tissue, no gross purulence. Type D Wound: Gross purulence/infected wound, no granulation tissue.
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
- 否
入选标准
- •Patient who has sustained an open fracture that requires surgical irrigation and debridement.
- •No gross clinical evidence of infection.
排除标准
- •A grossly infected open wound. Infection will be defined by clinical signs and symptoms of infection that include increasing drainage, increasing pain, purulent drainage, and increasing erythema. Any wounds that are thought to be infected will be cultured to confirm the diagnosis.
- •A surgical incision that can not be covered with VAC sponges and a water impermeable sheet (such as Ioban or Tegaderm) to achieve a closed vacuum environment over the wound.
- •Wounds associated with the surgical incision that are intentionally left open to heal with either a delayed primary closure or secondary granulation
- •Abnormal coagulation leading to an expanding hematoma that will require surgical debridement.
- •Pregnant women.
- •Inability or unwillingness to comply with protocol.
- •Patients or family members who are unable or unwilling to sign study informed consent.
结局指标
主要结局
Healing of Orthopaedic Trauma Open Fractures
时间窗: from surgery to wound closure
Healing of the open wound following orthopaedic trauma open fracture surgery was measured in days. (The wound has healed adequately to permit closure)
Infections
时间窗: Up to 12 months
Number of acute, delayed and deep wound infections.
次要结局
未报告次要终点