A Study to Evaluate NextScience® Xperience™ versus Normal Saline Irrigation Solution for Decreasing Bioburden After Primary Total Hip and Knee Arthroplasty

Overview

Información sobre este estudio

The purpose of this study is to determine the effectiveness of Next Science® Xperience™ Advanced Surgical Irrigation in reducing bacterial bioburden and acute periprosthetic joint infection rates after total hip and knee arthroplasty compared to standard of care irrigation.

 

 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Age ≥ 18 years or older.
  • Scheduled to undergo primary total hip (via direct anterior approach, press-fit components) or total knee arthroplasty (via manual approach, cemented components).
  • Willing to comply with all study-related procedures and be available for the duration of the study.
  • Provide signed and dated informed consent.

Exclusion Criteria:

  • Patient < 18 years of age.
  • Unable to provide signed and dated informed consent.
  • Unwilling or unable to comply with all study-related procedures.
  • Known history of sensitivity or allergic reaction to any of the study products or its components, including any products used for standard of care (such as dressings or any coverings).
  • Has underlying condition or state that, in the 'investigator's opinion, would make them too critically ill to complete the day 90 postoperative follow ups.
  • Pregnant, planning to become pregnant, or nursing female subjects.
  • Subject with any mental impairment or condition that would make them unable to properly consent without use of LAR or additional subject protections.
  • Subject is a prisoner and/or part of a vulnerable subject population, which necessitates additional human research subject protections beyond the scope of this protocol.
  • Subject with an active infection or systemic antibiotic therapy within 2 weeks prior to surgery with the exception of preoperative antimicrobial prophylaxis.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Cameron Ledford, M.D.

Cerrado; inscripción por invitación

¿Qué es esto? (?)
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El estudio no está abierto para todos los que cumplen con los criterios de elegibilidad, sino solamente para las personas que el equipo del estudio ha invitado a participar.

Contact information:

Stephanie Giles

Giles.Stephanie@mayo.edu

More information

Publicaciones

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CLS-20538651

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