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Aquacel Dressing for Allergic Skin Reactions

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 or unicompartmental knee arthroplasty (TKA/UKA)

Be older than 18 years old

Must not have

Revision surgery

Prior history of non-TJA or UKA surgery with AQUACEL Ag dressing post-op

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-3 weeks following surgery

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial will look at how often people getting hip or knee replacements can have allergic reactions to a dressing containing silver.

Who is the study for?

This trial is for adults over 18 who have had a first-time hip or knee replacement surgery. It's not for people with past allergic skin reactions, those exposed to surgical dressings at work, anyone with silver allergies, or patients having revision surgeries.

What is being tested?

The study is looking at the rate of skin allergies after using Aquacel Ag dressing in new hip and knee joint replacement patients compared to those who've had replacements before and used the same dressing.

What are the potential side effects?

Potential side effects include allergic contact dermatitis which can cause symptoms like redness, itching, and discomfort where the Aquacel dressing is applied.

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 knee replacement surgery.

Exclusion Criteria

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

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I am scheduled for or have had a revision surgery.

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I've had surgery that wasn't a total joint replacement and used AQUACEL Ag dressing afterwards.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-3 weeks following surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-3 weeks following surgery

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

Pivotal Trial

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

Drug Has Already Been Approved

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

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: Prior Aquacel groupExperimental Treatment1 Intervention

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

Group II: Arthroplasty-naïve Aquacel groupExperimental Treatment1 Intervention

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

0 / 3Eligibility criteria met