Surgiphor vs Saline Joints

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05434260

Enrollment

868

Registered

2022-06-27

Start date

2022-09-19

Completion date

2025-01-31

Last updated

2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prosthetic-joint Infection

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.

Interventions

DEVICESurgiphor Irrigation Solution

use of Surgiphor wound irrigation solution during surgery

DEVICESterile saline

Use of sterile saline as a irrigation solution during surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnosis of acute prosthetic joint infection	Within 90 days of revision surgery	Diagnosis of acute prothetic joint infection following aseptic revision surgery

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026