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临床试验/NCT01458223
NCT01458223已完成4 期

The Effect of Prolonged Postoperative Antibiotics Administration on Rate of Infection in Patients Undergoing Posterior Spine Surgery Requiring a Hemovac Drain

The London Spine Centre1 个研究点 分布在 1 个国家目标入组 645 人开始时间: 2011年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
645
试验地点
1
主要终点
Infection Rate

研究概览

简要总结

Post-operative antibiotics for infection prophylaxis are routinely given to most surgical patients, and for orthopaedic surgery patients, the standard of care is treatment for 24 hours following any elective procedure (1). The most concerning risk for insufficient antibiotic coverage in the post-operative period is the development of a complicated infection requiring irrigation and debridement or revision surgery. Moreover, recovery from surgery is usually delayed in patients that have postoperative wound infections leading to increased resource utilization and increased economic cost for the health care system. It is clear that prophylactic antibiotic therapy is necessary in the immediate post-operative period, but the length required continues to be debated.

Orthopaedic patients undergoing elective spine surgeries often require the placement of a hemovac drain which applies gentle suction to remove excess fluid/blood and to promote healing. Wound drains, however, may also increase the risk of post-operative infection because they expose the "clean" interior aspect of the wound to the "dirty" exterior area around the wound. Given this additional focus of infection, it is unknown whether prolonged antibiotic therapy post-operatively is needed to decrease the rate of infection in this population (2,3). There is sparse literature evaluating the effectiveness of prolonged antibiotic therapy in decreasing complicated post-operative infection requiring irrigation and debridement in this population (1,4). To our knowledge, there are no recent studies comparing prophylactic antibiotics for 24 hours only post-operatively versus 24 hours after removal of the drain. In fact, a recent evidence-based review of the literature by the North American Spine Society highlighted the need for research in this area (5).

The proposed study will compare two patient populations who will receive various lengths of post-operative antibiotics. One will receive only 24 hours worth, and the other will receive antibiotics for 72 hours after surgery and the rate of complicated infection compared between the two.

The absence of a demonstrable difference suggests that antibiotic prophylaxis for only 24 hours immediately post-operatively is sufficient for all elective spine patients undergoing posterior spine procedures requiring the placement of a hemovac drain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 16 and older
  • Require spine surgery for posterior lumbar decompressions, posterior thoracic decompressions, posterior cervical decompressions, posterior lumbar fusions, posterior thoracic fusions, posterior cervical fusions
  • English speaking and able to understand and provide informed consent

排除标准

  • Known hypersensitivity to antibiotics
  • Severe renal function impairments
  • Antibiotic therapy for concomitant infection at the time of surgery
  • Spine patients not requiring the insertion of a hemovac drain
  • Concomitant steroid therapy
  • Permanent residence more than a 5 hour driving distance away from Hospital

研究组 & 干预措施

Control

Active Comparator

24 hours post-operative antibiotics

干预措施: Antibiotic (Drug)

experimental

Experimental

72 hours of post-operative antibiotics

干预措施: Antibiotic (Drug)

结局指标

主要结局

Infection Rate

时间窗: one year

complicated wound infection requiring surgical irrigation and debridement

次要结局

未报告次要终点

研究者

发起方
The London Spine Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Christopher Bailey

Principal Investigator

The London Spine Centre

研究点 (1)

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