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Enrolling By InvitationNCT06440564

Laser Disinfection in Periprosthetic Joint Infection

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

Status
Enrolling By Invitation
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Medical University of Vienna · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREEr:YAG Laser irradiationThe 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.

Timeline

Start date
2021-11-01
Primary completion
2024-05-01
Completion
2025-05-01
First posted
2024-06-04
Last updated
2024-06-04

Locations

1 site across 1 country: Austria

Source: ClinicalTrials.gov record NCT06440564. Inclusion in this directory is not an endorsement.