Aquacel Hypersensitivity Dressing in TJAs

RECRUITING

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The aim of this multi-surgeon, single institution study is to prospectively evaluate the incidence of allergic contact dermatitis (ACD) following application of AQUACEL Ag, a silver-containing hydrofiber dressing, in total hip and knee arthroplasty patients. Arthroplasty-naïve patients will be compared to prior total joint arthroplasty patients who received a Aquacel dressing postoperatively.

Conditions:

Contact Allergic Dermatitis Adverse Skin Reaction

Study Start (Actual) 2023-08-18

Primary Completion (Estimated) 2024-10

Study Completion (Estimated) 2024-12-30

Enrollment (Estimated) 400

Study Type INTERVENTIONAL

Phase PHASE4

Locations:

📍 Chicago, Illinois, United States

Eligibility Criteria

Description

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

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2023-08-21
First Submitted that Met QC Criteria2023-08-21
First Posted2023-08-25

Study Record Updates

Last Update Submitted that Met QC Criteria2024-06-12
Last Update Posted2024-06-13
Last Verified2024-06