What side effects are associated with this type of intervention?

Common treatments for Prosthetic Joint Infection (PJI) using antiseptic solutions like povidone-iodine (PVP-I) irrigation can have several side effects. These may include local irritation, allergic reactions, and potential cytotoxicity to surrounding tissues. In some cases, systemic absorption can lead to thyroid dysfunction or metabolic imbalances, particularly with prolonged use. It is essential to monitor patients for these adverse effects and manage them promptly to ensure the safety and efficacy of the treatment.

What prior FDA approvals exist?

FDA-approved treatments for Prosthetic Joint Infection (PJI) often involve the use of systemic antibiotics and local antimicrobial agents. One notable approach includes the use of antibiotic-loaded bone cement, which has been shown to be effective in reducing infection risk during joint arthroplasty. This method combines antibiotics with bone cement to provide localized antimicrobial action directly at the surgical site. While specific antiseptic solutions like PVP-I irrigation are being studied, the current standard treatments focus on systemic antibiotics and antibiotic-loaded materials to manage and prevent infections.

What other types of research exist?

Promising alternatives to PVP-I irrigation solution for reducing infection risk in prosthetic joint infection patients include: 1) Teicoplanin-containing cement spacers, which have shown efficacy in experimental models of MRSA joint prosthesis infection. 2) Phage therapy, specifically phage cocktails like BFC 1.10, used in combination with antibiotics such as ceftazidime-avibactam, which have demonstrated potential in treating multidrug-resistant infections. These alternatives offer targeted antimicrobial action and may be effective in managing PJIs.

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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

Summary

This trial is testing a special cleaning solution called PVP-I (Surgiphor) to see if it can lower the risk of infections after hip and knee replacement surgeries. The solution is used to disinfect the surgical area, killing harmful germs. The study focuses on patients who are having these surgeries redone because they are at higher risk for infections.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Diagnosis of acute prosthetic joint infection

Secondary study objectives

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Prosthetic Joint Infection (PJI) include the use of antiseptic solutions like povidone-iodine (PVP-I) for irrigation, which works by releasing iodine that penetrates microbial cell walls, leading to the disruption of protein and nucleic acid structure and function, ultimately killing the pathogens. This antiseptic action is crucial for PJI patients as it helps to reduce the microbial load in the surgical site, thereby lowering the risk of infection and improving the chances of successful treatment outcomes. Additionally, combining antimicrobial therapy with surgical debridement and irrigation can enhance the effectiveness of infection control, especially in cases where implant retention is necessary.

Repopulation of periodontal pockets by microbial pathogens in the absence of supportive therapy.Infection prevention methodologies for lower extremity total joint arthroplasty.

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Who is running the clinical trial?

Center for Innovation and Research OrganizationLead Sponsor

6 Previous Clinical Trials

920 Total Patients Enrolled

~67 spots leftby Dec 2024

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