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Surgiphor vs Saline Joints

NCT05434260 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 868

Last updated 2023-09-11

No results posted yet for this study

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.

Conditions

  • Prosthetic-joint Infection

Interventions

DEVICE

Surgiphor Irrigation Solution

use of Surgiphor wound irrigation solution during surgery

DEVICE

Sterile saline

Use of sterile saline as a irrigation solution during surgery

Sponsors & Collaborators

  • Center for Innovation and Research Organization

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-19
Primary Completion
2024-12-31
Completion
2025-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05434260 on ClinicalTrials.gov