Status:
UNKNOWN
Surgiphor vs Saline Joints
Lead Sponsor:
Center for Innovation and Research Organization
Conditions:
Prosthetic-joint Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will be an open-label superiority, multicenter, single-blind, controlled randomized clinical trial investing the role of a PVP-I irrigation solution (Surgiphor) in reducing the risk of acut...
Eligibility Criteria
Inclusion
- Patient ≥18 years old
- Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
- Subjects scheduled to undergo total knee or total hip revision for aseptic reasons (per 2018 ICM criteria 5)
- Subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information. Subjects not willing to sign consent form to be randomized must be willing to sign alternate consent form to allow prospective data collection in the non-randomized arm of the study
Exclusion
- Subjects with known allergies to iodine or any other ingredients in Surgiphor
- Subjects unwilling to sign informed consent
- Subjects, for health reasons or other, in the opinion of the Investigator, with a life expectancy less than one year, which is the follow-up period of the study
Key Trial Info
Start Date :
September 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
868 Patients enrolled
Trial Details
Trial ID
NCT05434260
Start Date
September 19 2022
End Date
January 1 2025
Last Update
September 11 2023
Active Locations (4)
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1
University of Arizona
Phoenix, Arizona, United States, 85724
2
Lifebridge Health
Baltimore, Maryland, United States, 21215
3
University of Missouri
Columbia, Missouri, United States, 65212
4
Rothman Institute Orthopaedics
Philadelphia, Pennsylvania, United States, 19107