UnknownNot Applicable

Surgiphor vs Saline Joints

United States868 participantsStarted 2022-09-19

Plain-language 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 acute PJI in the 90 days following total hip and knee revision arthroplasty.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Diagnosis of acute prosthetic joint infection

Timeframe: Within 90 days of revision surgery

Trial details

NCT IDNCT05434260

SponsorCenter for Innovation and Research Organization

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2024-12

View on ClinicalTrials.gov More Prosthetic-joint Infection trials