Surgiphor vs Saline Joints

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Prosthetic-joint Infection
• Intervention / Treatment: Device: Surgiphor Irrigation Solution; Device: Sterile saline

• Study Type: Interventional
• Enrollment (Estimated): 868
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tiffany Morrison, MS; Phone Number: 7178561202; Email: tiffany@parvizisurgical.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85724
      • University of Arizona
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Lifebridge Health
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Institute Orthopaedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient ≥18 years old
2. Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
3. Subjects scheduled to undergo total knee or total hip revision for aseptic reasons (per 2018 ICM criteria 5)
4. 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:

1. Subjects with known allergies to iodine or any other ingredients in Surgiphor
2. Subjects unwilling to sign informed consent
3. 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgiphor: sterile povidone iodine irrigation solution; 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; use of Surgiphor wound irrigation solution during surgery
Placebo Comparator: Sterile saline	Device: Sterile saline; Use of sterile saline as a irrigation solution during surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Center for Innovation and Research Organization

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: Surgiphor01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No