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临床试验/NCT06440564
NCT06440564Enrolling By Invitation不适用

Laser Disinfection as Biofilm-Disrupter in Periprosthetic Joint Infection (PJI)

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
30
试验地点
2
主要终点
Biofil Eradication

研究概览

简要总结

The eradication of biofilms from infected implants is still an unsolved challenge. The high-energy light beam of an Er:YAG laser causes rapid heating and explosive ablation of tissue. In this study we test the suitability of this laser for the removal of biofilms from infected implant surfaces.

详细描述

Infections after joint arthroplasties represent a devastating and progressively escalating complication with increased morbidity and mortality. The eradication of biofilms from infected implants is still an unsolved challenge. The high-energy light beam of an Er:YAG laser causes rapid heating and explosive ablation of tissue. In this study the investigators test the suitability of this laser for the removal of biofilms from infected implant surfaces.

Methods In this prospective study, acute or early hematogenous periprosthetic joint infections (PJIs) will be treated with the modified procedure of Debridement, Antibiotics, Laser irradiation and Implant Retention (DALIR). The investigators compare the completeness of biofilm removal from the implant surface with mechanical cleansing alone and the additional use of Er:YAG laser light. Therefore, the investigators will obtain swab cultures from the implants on three distinct occasions: post-arthrotomy, subsequent to mechanical cleansing, and after Er:YAG laser irradiation. The investigators also compare the success rate of the DALIR procedure with the international literature.

Results The investigators expect, that the prevalence of viable microorganisms obtained from implant surfaces through swab cultures will be considerably diminished after additional Er:YAG laser therapy in comparison to only mechanical cleaning with LavaSurge®. The investigators hope to reach a higher healing rate in relation to comparable studies.

Conclusion If the hypothese is correct, the investigators will recommend the use of Er:YAG laser irradiation as an additional tool for disinfection of metal implants in PJIs whenever a DAIR procedure seems to be beneficial.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with periprosthetic joint infection (PJI) that will be treated with a debridement, antibiotics, and implant retention (DAIR) procedure

排除标准

  • When a DAIR procedure seems not beneficial in a PJI case.

结局指标

主要结局

Biofil Eradication

时间窗: 14 days

Primary outcome is the comparison of biofilm removal from the implant surface with mechanical cleansing alone (LavaSurge® administered with Pulsavac®) and the additional use of Er:YAG laser light. This is demonstrated by taking microbiological swabs from the implant surface before and after laser treatment.

次要结局

  • Healing Rate(1 year)

研究者

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

Lukas Kriechbaumer

MD

Paracelsus Medical University

研究点 (2)

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