Intraoperative Disinfection by Pulse Irrigation With Povidone-Iodine Solution in Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Number of Participants With surgical site infection
研究概览
简要总结
The purpose of this study was to evaluate the efficacy, in preventing Spinal Surgical Infection, of intraoperative pulsatile irrigation with a 2000-ml saline solution of PVP-Iodine in a group of patients undergoing complex spine surgery with a posterior approach. To confirm and better assess the efficacy of intraoperative irrigation on the infection rate in spinal surgery, specimens for bacterial culture were harvested by swabs from muscular tissue before and after irrigation of the wounds
详细描述
The investigators enrolled fifty patients undergoing spinal surgery were randomly divided in two subgroups (A and B) of 25 patients each. In subgroup A, wounds were irrigated with dilute (3%) povidone-iodine solution through a low-pressure pulsatile device. In subgroup B wounds were irrigated with normal saline solution thorough a bulb syringe. In both subgroup specimens for bacterial culture were harvested by swabs from surgical site before and after irrigation of the wounds.
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and Female
- •Patients candidated to spinal surgery for spinal surgery
- •Primary spinal surgery procedure
排除标准
- •Clinical signs of infection before surgery
- •Previous spinal surgery
研究组 & 干预措施
Group A - Pulsed PVP-I Irrigation
Group in wich the patients who underwent spinal surgery were treated with 5-10 minutes of low-pressure irrigation with Povidone-Iodine (PVP-I) diluted to a 3% concentration (30g/l) in 2 l of saline performed before applying the bone graft
干预措施: Group A - Pulsed PVP-I Irrigation (Procedure)
Group B - Pulsed Saline Irrigation
Group in wich the patients who underwent spinal surgery were treated with 5-10 minutes of low-pressure irrigation with only 2 litres of saline solution (without povidone Iodine) performed before applying the bone graft
干预措施: Group A - Pulsed PVP-I Irrigation (Procedure)
结局指标
主要结局
Number of Participants With surgical site infection
时间窗: From the surgery to 1 year after
Comparison of the results obtained from microbiological bacterial cultures of samples harvested during complex spine surgery in two groups of patients treated intraoperatively with pulsatile irrigation with diluted PVP-I (group A) or pulsatile irrigation with saline solution (group B)
次要结局
未报告次要终点
研究者
Gabriele Bernardi
MD
University of Rome Tor Vergata