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Prineo Dressing Sensitivity for Allergy

Phase 4

Recruiting

Led By Vasili Karas, MD

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

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

Must have

Patients older than 18 years that underwent primary total joint arthroplasty (total hip, total knee, partial knee)

Be older than 18 years old

Must not have

Revision surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-3 weeks after surgery

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial will assess the rate of allergic reactions to Prineo dressing in patients undergoing TJA. It will compare reactions in those who have never had Prineo dressings before to those with previous exposure.

Who is the study for?

This trial is for patients over 18 years old who have had a primary total joint replacement (hip, knee, or partial knee) and haven't used Prineo dressing before. It's not for those with a history of allergic skin reactions or who need revision surgery.

What is being tested?

The study tests if there's a difference in allergic reactions to Prineo dressings between first-time users and those who've had it before after joint replacement surgery. The reaction rates are checked one week post-op and at the first clinic visit, 2-3 weeks later.

What are the potential side effects?

Possible side effects include skin redness, hives, eczema-like rash around the surgical cut due to an allergic response to Prineo dressing. These can lead to more doctor visits or even additional surgeries.

Eligibility Criteria

Inclusion Criteria

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

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I am over 18 and had a hip or knee replacement surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am scheduled for or have had revision surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-3 weeks after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-3 weeks after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-3 weeks after 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

Rate of contact allergic dermatitis or adverse skin reaction at 1 week post surgery

Rate of contact allergic dermatitis or adverse skin reaction at 2-3 weeks post surgery

Secondary study objectives

Wound complications (if applicable)

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Prineo-exposed groupExperimental Treatment1 Intervention

All subject's receive the Prineo dressing, this group is comprised of patients who have undergone previous joint replacement surgery (hip or knee) and have had a prineo dressing. This also includes patients who have had prior exposure to glue/mesh dressing either as a patient or healthcare worker.

Group II: Prineo naive groupExperimental Treatment1 Intervention

All subject's receive the same dressing, this group is comprised of patients consented to the study and will receive the Prineo dressing but have not had previous joint replacement surgery. Therefore, we consider them Prineo-naive.

0 / 2Eligibility criteria met