跳至主要内容
临床试验/NCT02527512
NCT02527512已完成4 期

Bacterial Wound Contamination Prior to Closure: Povidone-Iodine Versus Saline Irrigation in Pediatric Spine Fusion Surgery

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2017年7月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
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

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

Active Comparator

0.35% povidone-iodine ("Betadine")

干预措施: Povidone-Iodine (Drug)

Normal Saline

Active Comparator

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

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

Michael Glotzbecker

Assistant Professor, Orthopaedic Surgery

Boston Children's Hospital

研究点 (2)

Loading locations...

相似试验