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临床试验/NCT01577524
NCT01577524终止2 期

The Use of Diluted Povidone Iodine Irrigation in Spine Surgery

Attabib, Najmedden, M.D.1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
发起方
入组人数
58
试验地点
1
主要终点
Number of post-operative infections diagnosed in both treatment and control groups

研究概览

简要总结

The purpose of the study is to determine whether diluted Povidone Iodine solution used to irrigate surgical wounds during spine surgery decreases the incidence of surgical site infections.

详细描述

Post-operative infections in spine surgery have been extensively investigated in the literature. These investigations focus on the efficacy of using peri-operative antibiotics, Povidone Iodine skin preparations, the effects of shaving around the surgical sit, and the use of intra-operative diluted Povidone Iodine wound irrigation in preventing post-operative infections.

Povidone-iodine is a complex of polyvinyl pyrrolidine and tri-iodine ions widely used as an antiseptic agent. It has bactericidal activity against a wide spectrum of pathogens, including methicillin-resistant Staphylococcus aureus (MRSA). The safety of its use intra-operatively has been evaluated in animal studies and also supported through Randomized Controlled Trials in spinal surgery and in other surgical subspecialties.

The purpose of this study is to evaluate the efficacy of the intra-operative use of diluted Povidone Iodine solution in reducing post-operative infections when used for irrigating surgical incisions during spinal surgery compared with 0.9% Sodium Chloride Irrigation Solution (i.e. normal saline solution).

The primary outcome measure will be seen as a reduction in the number of post-operative infections. As a result and although not directly measured, it is suspected that a reduction in post-operative infections may result in quicker healing with fewer complications and pain.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age of 18-75
  • Undergoing posterior surgical spinal procedure for degenerative spine disease, extra-dural tumors, trauma, or spinal deformity
  • No obvious potential infective focus
  • Patient willing to enroll

排除标准

  • Age <18 or >75
  • Identified infective focus in the body, including furuncles,or acne at surgical incision site
  • Patient with discitis or spinal osteomyelitis
  • Dural tear
  • Potential use of Bone Morphogenic Protein (BMP)
  • Iodine hypersensitivity
  • Out of province patients due to difficulty in arranging follow up visits
  • Minimal invasive spine surgical procedure (MISS) due to difficulty of having diluted Betadine solution contact soft tissue with the use if MISS retractors
  • Pregnancy
  • Inability to provide informed consent

研究组 & 干预措施

Diluted Povidone Iodine Solution

Active Comparator

干预措施: Povidone-Iodine (Drug)

Normal Saline Wash

Placebo Comparator

干预措施: Saline (Drug)

结局指标

主要结局

Number of post-operative infections diagnosed in both treatment and control groups

时间窗: Twelve months post operation

The Centers for Disease Control (CDC)definition of surgical site infections (SSI)will be used for this study.This definition addresses both superficial and deep surgical site infections. Outcome will be determined by the number of superficial, deep, and total (superficial plus deep) wound infections for each group.

次要结局

未报告次要终点

研究者

发起方
Attabib, Najmedden, M.D.
申办方类型
Indiv
责任方
Principal Investigator
主要研究者

Dr. Najmedden Attabib

Principle Investigator

Attabib, Najmedden, M.D.

研究点 (1)

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