跳至主要内容
临床试验/NCT05402995
NCT05402995终止4 期

Prospective Randomized Control Trial Comparing Irrisept to Saline Irrigation for the Prevention of Infection After Open Tibia Fractures

Brett D. Crist1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2022年6月21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
终止
发起方
入组人数
6
试验地点
1
主要终点
Number of Participants Experiencing Surgical Site Infection (SSI)

研究概览

简要总结

Early debridement and definitive fixation, at the initial operative setting, historically led to no difference in the infection rates for Gustilo-Anderson type III open tibia fractures. However, Lenarz et al. reported that delaying definitive fixation in open tibia fractures could decrease the deep infection rate. At the University of Missouri, the investigators found that staged procedures, including initial debridement-temporary fixation and delayed definitive fixation, did not statistically decrease the rate of deep infection in Gustilo-Anderson type III fractures, prompting the study that is being proposed here. Antibiotic cement coated intramedullary nails have been used in management of infected long bone fractures. Since external fixation and staged debridement did not decrease type III open tibia infection rate, the investigators wanted to consider using antibiotic cement coated nails to deliver antibiotics locally in the acute open fracture setting to prophylactically decrease associated infection rate. Additionally, Irrisept is a wound irrigant that has been used to lower infection rates in different wound settings. To the investigators' knowledge, there are no robust data showing its effectiveness at lowering infection rates in open tibia fracture management. The purpose of this study is to determine the effects of Irrisept and antibiotic nails on lowering deep infection rates in type III open tibia fractures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Adult, 18 or over
  • Gustilo-Anderson type III open tibia fracture
  • Able to obtain informed consent from patient

排除标准

  • Minor, under 18
  • Allergic to chlorhexidine gluconate
  • Allergic to vancomycin or tobramycin
  • Patient's tibia is unable to accommodate the smallest antibiotic nail
  • Unable to provide informed consent

研究组 & 干预措施

Standard operative debridement and spanning external fixator (reference/control group)

Active Comparator

This is the standard of care management. Patient will go to the operating room (OR) first for irrigation and debridement with normal saline and external fixation. Will return to OR at a later date for definitive fixation.

干预措施: Saline (Drug)

Spanning external fixator with Irrisept irrigation (treatment group 1)

Experimental

Patient will go to the operating room (OR) first for irrigation and debridement with Irrisept (the experimental irrigation solution) and external fixation. Will return to OR at a later date for definitive fixation.

干预措施: Irrisept (Irrigation Solution) (Drug)

Antibiotic-coated medullary nail with saline irrigation (treatment group 2)

Experimental

Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with normal saline.

干预措施: Saline (Drug)

Antibiotic-coated medullary nail with Irrisept irrigation (treatment group 3)

Experimental

Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with Irrisept (the experimental irrigation solution).

干预措施: Irrisept (Irrigation Solution) (Drug)

结局指标

主要结局

Number of Participants Experiencing Surgical Site Infection (SSI)

时间窗: 90 days

Measured by the number of surgical site infections in the total population of patients.

次要结局

  • Number of Participants With Fracture Healing(6 months)

研究者

发起方
Brett D. Crist
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Brett D. Crist

Professor, Director Orthopaedic Trauma Service, Director Orthopaedic Trauma Fellowship, Surgery of the Hip and Trauma, Department of Orthopaedic Surgery

University of Missouri-Columbia

研究点 (1)

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