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Aquacel Hypersensitivity Dressing in TJAs
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) 18 August 2023
🗓️ Primary Completion (Estimated) October 2024
✅ Study Completion (Estimated) 30 December 2024
👥 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 Submitted 21 August 2023
  • First Submitted that Met QC Criteria 21 August 2023
  • First Posted 25 August 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 June 2024
  • Last Update Posted 13 June 2024
  • Last Verified June 2024
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