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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-3 weeks after surgery

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am over 18 and had a hip or knee replacement 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

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

Primary outcome measures

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 outcome measures

Wound complications (if applicable)

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

163,101 Total Patients Enrolled

Vasili Karas, MDPrincipal InvestigatorRush University Medical Center

Frequently Asked Questions

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

Has the Prineo naive group been cleared for commercialization by the FDA?

"The safety of Prineo naive group is rated a 3 due to the fact this intervention has achieved Phase 4 status, implying approval from regulatory bodies."

Answered by AI

Is participation in this trial still available to prospective volunteers?

"Confirmed, the clinical trial is actively seeking participants. As per information provided by clinicaltrials.gov, this study was initially posted on August 17th 2023 and has recently been updated on August 21st 2023. This investigation requires 400 volunteers to be recruited from one medical site."

Answered by AI

To what extent are patients being administered this clinical trial?

"Affirmative. Clinicaltrials.gov exhibits that this medical investigation, initially advertised on August 17th 2023 is actively enrolling patients. 400 participants are being accepted from a single site before the trial closes again."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prineo Sensitivity Dressing Study

2023. "Prineo Sensitivity Dressing Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06011603.