Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440564
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-04
First Post:
2024-05-24
Brief Title:
Laser Disinfection in Periprosthetic Joint Infection
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Laser Disinfection as Biofilm-Disrupter in Periprosthetic Joint Infection PJI
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The eradication of biofilms from infected implants is still an unsolved challenge The high-energy light beam of an ErYAG 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 ErYAG 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 ErYAG laser light Therefore the investigators will obtain swab cultures from the implants on three distinct occasions post-arthrotomy subsequent to mechanical cleansing and after ErYAG 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 ErYAG 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 ErYAG laser irradiation as an additional tool for disinfection of metal implants in PJIs whenever a DAIR procedure seems to be beneficial
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 ErYAG laser light Therefore the investigators will obtain swab cultures from the implants on three distinct occasions post-arthrotomy subsequent to mechanical cleansing and after ErYAG 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 ErYAG 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 ErYAG laser irradiation as an additional tool for disinfection of metal implants in PJIs whenever a DAIR procedure seems to be beneficial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None