Aquacel Hypersensitivity Dressing in TJAs

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

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.

Study Overview

• Status: Completed
• Conditions: Contact Allergic Dermatitis; Adverse Skin Reaction
• Intervention / Treatment: Device: Aquacel dressing

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)

• Study Type: Interventional
• Enrollment (Actual): 396
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arthroplasty-naïve Aquacel group; 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.	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.
Other: Prior Aquacel group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of contact allergic dermatitis or adverse skin reaction at 1 week post surgery	Using a classification of skin reactions from mild, moderate to severe	7 days post surgery
Rate of contact allergic dermatitis or adverse skin reaction at 2-3 weeks post surgery	Using a classification of skin reactions from mild, moderate to severe	2-3 weeks following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound complications (if applicable)	If patients present with wound complications, require possible work up for infection, require antibiotics outside of normal protocol due to concerns of infection, return to the operating room, confirmed periprosthetic joint infection or stiffness that requires a manipulation under anesthesia	1 week post surgery
Wound complications (if applicable)	If patients present with wound complications, require possible work up for infection, require antibiotics outside of normal protocol due to concerns of infection, return to the operating room, confirmed periprosthetic joint infection or stiffness that requires a manipulation under anesthesia	2-3 weeks after surgery

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Vasili Karas, MD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2023
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): June 3, 2025

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Dermatitis, Contact; Hypersensitivity; Dermatitis, Atopic; Dermatitis; Dermatitis, Allergic Contact; Gastrointestinal Agents; Laxatives; Carboxymethylcellulose Sodium
• Other Study ID Numbers: 23050308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Once complete, we will share the summary of the data along with study protocol and SAP
• IPD Sharing Time Frame: Once the study is fully enrolled
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes