Surgiphor vs Saline Joints

Study Overview
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Brief Summary
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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.

Official Title
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The Use of Povidone-iodine Sterile Solution to Reduce Periprosthetic Joint Infections: a Superiority Multicentre Randomized Trial

Conditions
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Prosthetic-joint Infection

Intervention / Treatment
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* Device: Surgiphor Irrigation Solution
* Device: Sterile saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgiphor: sterile povidone iodine irrigation solution<br>Surgiphor Wound Irrigation Solution, bottle consisting of sterile 0.5% PVP-I formulation with 0.9% saline, Potassium Iodide, Phosphate Buffer, Vitamin E TPGS | Device: Surgiphor Irrigation Solution<br>* use of Surgiphor wound irrigation solution during surgery<br>|
| Placebo Comparator: Sterile saline<br> | Device: Sterile saline<br>* Use of sterile saline as a irrigation solution during surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of acute prosthetic joint infection | Diagnosis of acute prothetic joint infection following aseptic revision surgery | Within 90 days of revision surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound complications | Diagnosis of wound complication, surgical site infections or other infections within 1 year of surgery | within 1 year of revision surgery |