Bacterial Wound Contamination Prior to Closure: Povidone-Iodine Versus Saline Irrigation in Pediatric Spine Fusion Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 2
- 主要终点
- Culture Positivity
研究概览
简要总结
This study will evaluate the safety of povidone-iodine irrigation in pediatric spinal patients by collecting pre- and post-operative safety labwork. Furthermore, the efficacy of povidone-iodine and normal saline irrigation at reducing bacterial contamination of the surgical wound will be measured by collecting cultures before and after irrigation.
详细描述
Previous research has shown there is baseline bacterial contamination of surgical spinal wounds prior to closure. While this bacterial contamination may or may not lead to infection, recent adult studies demonstrated reduced infection rates by using povidone-iodine irrigation before closure. This study will determine the safety of using povidone-iodine irrigation in pediatric spinal patients and how effective it is at reducing bacterial contamination of the spinal surgical wound prior to closure, compared with normal saline. The investigators hypothesize povidone-iodine is both safe and effective. Understanding techniques that reduce the local bacterial load in the wound prior to closure after spinal fusion will give data to support measures that will ultimately reduce the rate of postoperative infections.
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 (Participant)
入排标准
- 年龄范围
- 3 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 3 to 18 years on day of surgery
- •diagnosis of spinal deformity
- •undergoing elective posterior spine multi-level instrumentation surgery
排除标准
- •Documented renal failure
- •documented allergy to iodine or shellfish
- •previous spine fusion surgery
- •undergoing elective posterior spine single-level instrumentation surgery
- •undergoing anterior spine multi-level instrumentation surgery
- •current antibiotic use.
研究组 & 干预措施
Povidone-Iodine
0.35% povidone-iodine ("Betadine")
干预措施: Povidone-Iodine (Drug)
Normal Saline
Sterile sodium chloride (NaCl) solution
干预措施: Normal Saline (Other)
结局指标
主要结局
Culture Positivity
时间窗: Cultures taken before and after irrigation during surgery
Assess feasibility of a larger randomized controlled trial using significance of differences in the bacteriology and contamination rates of both treatment arms. Also measured baseline tissue colonization rates.
次要结局
- Risk Groups(Cultures taken before and after irrigation during surgery)
研究者
Michael Glotzbecker
Assistant Professor, Orthopaedic Surgery
Boston Children's Hospital
