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Antiseptic Solution

Surgiphor Solution for Preventing Infections After Joint Surgery

N/A

Waitlist Available

Research Sponsored by Center for Innovation and Research Organization

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must provide informed consent after explanation of 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

Subjects scheduled to undergo total knee or total hip revision for aseptic reasons (per 2018 ICM criteria 5)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 90 days of revision surgery

Awards & highlights

Study Summary

This trial will investigate if a solution can reduce the risk of infections after hip and knee arthroplasty.

Who is the study for?

This trial is for adults over 18 who need a total hip or knee revision surgery and can give informed consent. It's not for those with iodine allergies, life expectancy less than one year, or women who are pregnant or breastfeeding.Check my eligibility

What is being tested?

The study compares Surgiphor irrigation solution to sterile saline in preventing joint infections after hip or knee replacement surgeries. Participants will be randomly assigned to receive either Surgiphor or saline during their procedure.See study design

What are the potential side effects?

Potential side effects may include reactions related to iodine sensitivity such as skin irritation or allergic responses for those receiving the Surgiphor solution.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand the study, its risks, and agree to participate by signing the consent form.

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I am scheduled for a knee or hip revision surgery due to non-infectious reasons.

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I am a man, or I am a woman who is not pregnant, not breastfeeding, and cannot have children.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 90 days of revision surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 90 days of revision surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 90 days of revision surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Diagnosis of acute prosthetic joint infection

Secondary outcome measures

Wound complications

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Surgiphor: sterile povidone iodine irrigation solutionActive Control1 Intervention

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

Group II: Sterile salinePlacebo Group1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Center for Innovation and Research OrganizationLead Sponsor

6 Previous Clinical Trials

920 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How widely dispersed are the locations of this clinical trial?

"The research project is being conducted at four different institutions, including Lifebridge Health in Baltimore, University of Missouri in Columbia and Rothman Institute Orthopaedics in Philadelphia. Additionally there are a further 4 sites with open trials."

Answered by AI

Are there still vacancies available for participants in this trial?

"As indicated on clinicaltrials.gov, this medical trial is not currently seeking new patient enrolment as the original posting date was September 19th 2022 and it has since been updated to a status of "not recruiting" on September 7th 2023. Nevertheless, there are presently 747 other studies actively looking for participants across the world."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Surgiphor vs Saline Joints

2022. "Surgiphor vs Saline Joints". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05434260.