An interventional study of Er:YAG Laser irradiation in Periprosthetic Joint Infections, sponsored by Medical University of Vienna. Enrolling by invitation at 1 site in Austria. Per ClinicalTrials.gov, last updated 2024-06-04.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Treatment
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.
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.
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This study's planned enrollment of 30 is below the median of 120 across 4,200 interventional studies indexed under Infections.
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Exclusion Criteria:
In addition to the standard DAIR procedure, laser light is used to disrupt the biofilm from implant surfaced.
Procedure: Er:YAG Laser irradiation
The presented DALIR procedure differs in so far from a standard treatment that after exposure all accessible metal implant surfaces and the adjacent soft tissue is irradiated manually with the Er:YAG laser all over line-by-line with an intended overlap of approximately 10% at constant spot diameter.
Also known as: Mechanical cleaning with LavaSurge®
Biofil Eradication
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.
Time frame: 14 days
Healing Rate
Secondary outcome is infection eradication at 1 year following the DALIR procedure. Success of a DALIR procedure will be determined by the absence of antibiotic administration, lack of clinical indications of infection, and absence of infection related subsequent surgical procedures.
Time frame: 1 year
Plan to share: No
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Medical University of Vienna