Surgiphor vs Saline Joints

Center for Innovation and Research Organization

Status: Invitation-only

Conditions: Prosthetic-joint Infection

Treatments: Device: Sterile saline; Device: Surgiphor Irrigation Solution

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05434260

Surgiphor01

Details and patient eligibility

About

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.

Enrollment: 868 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

868 participants in 2 patient groups, including a placebo group

Surgiphor: sterile povidone iodine irrigation solution

Active Comparator group

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

Treatment:

Device: Surgiphor Irrigation Solution

Sterile saline

Placebo Comparator group

Treatment:

Device: Sterile saline