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

Part of paid clinical trials in Manhasset, New York.

Sponsor
Northwell Health
Study ID
NCT05519007
Status
Recruiting
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Conditions

  • Joint Infection

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • No-Rinse Solution (NS) — OTHER
    The surgical site will be irrigated with NS prior to closure,
  • Saline irrigation — OTHER
    The surgical site will be irrigated with Saline

Study Details

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

Key Dates

Start date
Sep 26, 2023
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
936 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: The Next Science treatment
    The surgical site will be irrigated with NS prior to closure, which will be suctioned at the end of the treatment time
  • Active Comparator: Standard of Care
    Saline irrigation

Primary Outcome Measure

infection rate [ Time Frame: at 90 days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
North Shore University HospitalManhassetNew York11030
Meriton Ruhani
Long Island Jewish Medical CenterNew Hyde ParkNew York11040
Meriton Ruhani
Lenox Hill HospitalNew YorkNew York10075
Meriton Ruhani
[email protected]

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North Shore University Hospital· Manhasset, NYLong Island Jewish Medical Center· New Hyde Park, NYLenox Hill Hospital· New York, NY

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