Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNorthwell Health

About this trial

A prospective, single-site, double-arm, parallel, interventional, randomized, controlled clinical trial to assess 90-day rate of joint infections in subjects undergoing primary hip replacements after administration of Next Science No-Rinse Solution (hereby referred to as NS) vs SOC (saline irrigation). The Next Science treatment arm will exhibit greater reduction in rate of 90-day post-operative joint infection than SOC (saline) arm

Eligibility criteria

Qualifiers

American Society of Anesthesiologists (ASA) 3 2

BMI >35

Poorly treated hypertension

Poorly treated diabetes

Disqualifiers

Unable to provide signed and dated informed consent.

Unable or unwilling to comply with all study-related procedures.

Known history of 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)

Subject has contraindications to general anesthesia

Trial design

Treatments tested in this trial

  • No-Rinse Solution (NS)
  • Saline irrigation

Treatment groups

936 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Northwell Health

Lead sponsor

Next Science TM

Collaborator