NCT06011629

Aquacel Hypersensitivity Dressing in TJAs

Prospective Evaluation of Type IV Hypersensitivity Reactions After Aquacel Dressing Application in Partial and Total Joint Arthroplasty Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 396 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Level I: Prospective Cohort Study Patients will be recruited into the study after completing a standard questionnaire for pre-operative enrollment. After meeting inclusion criteria and passing the screening process, the patient will be enrolled into the study. Variables of interest related to sociodemographic status, operative details and postoperative outcomes. Sample Size: A power analysis to determine how many patients need to be enrolled was performed with a rate of ACD in the AQUACEL Ag naïve group and the AQAUCEL Ag-exposed group of 1% and 2%, respectively. A one-tailed z-test of proportions between the two groups with 80% power, a 5% level of significance, and 1:1 allocation ratio, requires a sample size of 314 (157 per group). To account for 20% attrition rate amongst both cohorts, we plan to enroll 400 patients (200 each group). Demographic/Patient Specific Data Collected: Age, Sex, Body Mass Index (BMI), Allergy History, Past Surgical History, Prior exposure to surgical dressing (Either occupational (i.e. healthcare worker) or as a patient), Number of prior arthroplasty surgeries with AQUACEL Ag dressing (i.e. 0, 1, 2, 3), Past adverse reaction to AQUACEL Ag dressing, Any Adverse Skin Reactions with any past adhesive exposure Operative details: Surgical date, Operation/Laterality (THA/TKA/UKA, Left/Right), Length of incision, Patient reported skin check at 1 week (via picture from patient if wound issue/skin reaction present), Size of Rash if present, Provider skin Check at 1st post-operative appointment (2-4 weeks post-op), Any Wound Complications Primary Outcome Measure: The primary outcome is the rate of contact allergic dermatitis or adverse skin reaction at 1 week post op and 1st post operative visit (2-3 weeks after surgery). We will also quantify time from surgery to reaction onset (Days). We will measure the size of the rash at post-operative follow up as well as classify the rash according to the classification system used in prior studies examining ACD. Secondary Outcome Measures 1. Wound complications 2. Any workup for PJI (Serologic labs (ESR/CRP), arthrocentesis) 3. Any administration of post-operative antibiotics outside of normal protocol 4. Return to Operating Room for debridement, manipulation, other surgical interventions 5. Surgical Site Infection (SSI) 6. Confirmed Periprosthetic Joint Infection (PJI) 7. Stiffness requiring Manipulation Under Anesthesia (MUA)

Conditions

• Contact Allergic Dermatitis
• Adverse Skin Reaction

Interventions

Type	Name	Description
DEVICE	Aquacel dressing	Patients will be recruited into the study after completing a standard questionnaire for pre-operative enrollment. After meeting inclusion criteria and passing the screening process, the patient will be enrolled into the study. Arthroplasty-naïve patients will be compared to prior total joint arthroplasty patients who received a Aquacel dressing postoperatively.

Timeline

• Start date: 2023-08-18
• Primary completion: 2024-11-01
• Completion: 2025-06-03
• First posted: 2023-08-25
• Last updated: 2025-06-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study