Surgiphor vs Saline Joints
Status unconfirmed · Not applicable
Conditions studied: Prosthetic-joint Infection
In brief
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 acute PJI in the 90 days following total hip and knee revision arthroplasty.
Key facts
- Study ID
- NCT05434260
- Run by
- Center for Innovation and Research Organization
- People needed
- 868
- Starts
- 2022-09-19
- Expected to finish
- 2025-01-01
- Last updated by the study team
- 2023-09-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Arizona — Phoenix, Arizona, United States
- Lifebridge Health — Baltimore, Maryland, United States
- University of Missouri — Columbia, Missouri, United States
- Rothman Institute Orthopaedics — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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