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Surgiphor vs Saline Joints

Primary Purpose

Prosthetic-joint Infection

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surgiphor Irrigation Solution
Sterile saline
Sponsored by
Center for Innovation and Research Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prosthetic-joint Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arizona
  • Lifebridge Health
  • University of Missouri
  • Rothman Institute Orthopaedics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Surgiphor: sterile povidone iodine irrigation solution

Sterile saline

Arm Description

Surgiphor Wound Irrigation Solution, bottle consisting of sterile 0.5% PVP-I formulation with 0.9% saline, Potassium Iodide, Phosphate Buffer, Vitamin E TPGS

Outcomes

Primary Outcome Measures

Diagnosis of acute prosthetic joint infection
Diagnosis of acute prothetic joint infection following aseptic revision surgery

Secondary Outcome Measures

Wound complications
Diagnosis of wound complication, surgical site infections or other infections within 1 year of surgery

Full Information

First Posted
June 22, 2022
Last Updated
September 7, 2023
Sponsor
Center for Innovation and Research Organization
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1. Study Identification

Unique Protocol Identification Number
NCT05434260
Brief Title
Surgiphor vs Saline Joints
Official Title
The Use of Povidone-iodine Sterile Solution to Reduce Periprosthetic Joint Infections: a Superiority Multicentre Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Innovation and Research Organization

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthetic-joint Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
868 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgiphor: sterile povidone iodine irrigation solution
Arm Type
Active Comparator
Arm Description
Surgiphor Wound Irrigation Solution, bottle consisting of sterile 0.5% PVP-I formulation with 0.9% saline, Potassium Iodide, Phosphate Buffer, Vitamin E TPGS
Arm Title
Sterile saline
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Surgiphor Irrigation Solution
Intervention Description
use of Surgiphor wound irrigation solution during surgery
Intervention Type
Device
Intervention Name(s)
Sterile saline
Intervention Description
Use of sterile saline as a irrigation solution during surgery
Primary Outcome Measure Information:
Title
Diagnosis of acute prosthetic joint infection
Description
Diagnosis of acute prothetic joint infection following aseptic revision surgery
Time Frame
Within 90 days of revision surgery
Secondary Outcome Measure Information:
Title
Wound complications
Description
Diagnosis of wound complication, surgical site infections or other infections within 1 year of surgery
Time Frame
within 1 year of revision surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Lifebridge Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Rothman Institute Orthopaedics
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

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Surgiphor vs Saline Joints

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