Surgiphor vs Saline Joints
The Use of Povidone-iodine Sterile Solution to Reduce Periprosthetic Joint Infections: a Superiority Multicentre Randomized Trial
1 other identifier
interventional
868
1 country
4
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 acute PJI in the 90 days following total hip and knee revision arthroplasty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2022
CompletedFirst Posted
Study publicly available on registry
June 27, 2022
CompletedStudy Start
First participant enrolled
September 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedSeptember 11, 2023
September 1, 2023
2.2 years
June 22, 2022
September 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnosis of acute prosthetic joint infection
Diagnosis of acute prothetic joint infection following aseptic revision surgery
Within 90 days of revision surgery
Secondary Outcomes (1)
Wound complications
within 1 year of revision surgery
Study Arms (2)
Surgiphor: sterile povidone iodine irrigation solution
ACTIVE COMPARATORSurgiphor Wound Irrigation Solution, bottle consisting of sterile 0.5% PVP-I formulation with 0.9% saline, Potassium Iodide, Phosphate Buffer, Vitamin E TPGS
Sterile saline
PLACEBO COMPARATORInterventions
use of Surgiphor wound irrigation solution during surgery
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Arizona
Phoenix, Arizona, 85724, United States
Lifebridge Health
Baltimore, Maryland, 21215, United States
University of Missouri
Columbia, Missouri, 65212, United States
Rothman Institute Orthopaedics
Philadelphia, Pennsylvania, 19107, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2022
First Posted
June 27, 2022
Study Start
September 19, 2022
Primary Completion
December 1, 2024
Study Completion
January 1, 2025
Last Updated
September 11, 2023
Record last verified: 2023-09