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Aquacel Dressing for Allergic Skin Reactions

Phase 4

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-3 weeks after surgery

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am over 18 and had a 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: 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 / 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

Frequently Asked Questions

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

Are there vacancies available for participants in this research program?

"According to clinicaltrials.gov, this medical trial is presently engaging patients for participation. It was initially posted on August 18th 2023 and last modified on August 21st of the same year."

Answered by AI

Has the Arthroplasty-naïve Aquacel group obtained regulatory approval from the Food and Drug Administration?

"Our experts at Power rated the safety of Arthroplasty-naïve Aquacel group as 3, due to it being a Phase 4 trial and hence having approval for use."

Answered by AI

What is the upper boundary of participants in this experiment?

"Affirmative, clinicaltrials.gov hosts information indicating that this trial is actively recruiting participants. Originally posted on August 18th 2023 and last edited three days later, the study seeks 400 patients from one site to complete the research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Aquacel Hypersensitivity Dressing in TJAs

2023. "Aquacel Hypersensitivity Dressing in TJAs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06011629.