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Could a common wound dressing trigger allergic skin reactions?

NCT ID NCT06011629

Knowledge-focused Sponsor: Rush University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This study looks at whether Aquacel, a silver-containing wound dressing used after hip or knee replacement surgery, can cause allergic contact dermatitis—a type of skin rash. Researchers will compare patients having their first joint replacement with those who had a previous joint replacement and received Aquacel. The goal is to measure how often skin reactions occur and how severe they are, to better understand the safety of this dressing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aquacel dressing (a silver-containing wound dressing)
What this could lead to
If it works, this could help identify which patients are at risk of skin reactions from Aquacel dressings, potentially guiding safer post-surgery wound care.
What could go wrong
This is a single-institution study, and results may not apply to all patients. Skin reactions are relatively uncommon, and the study may not capture all cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

457 people

The number who actually took part.

Started

Jun 2023

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients older than 18 years that underwent primary total hip arthroplasty (THA) 2. Patients older than 18 years that underwent primary total or unicompartmental knee arthroplasty (TKA/UKA) Exclusion Criteria: 1. Revision surgery 2. Prior history of allergic contact dermatitis 3. Prior history of non-TJA or UKA surgery with AQUACEL Ag dressing post-op 4. Occupational exposure to surgical dressings 5. Documented history of silver allergy

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Conditions

The condition(s) this trial relates to.

allergic contact dermatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adverse skin reaction Contact allergic dermatitis

Contacts and locations

Locations

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States