Aquacel Hypersensitivity Dressing in TJAs

NCT ID: NCT06011629

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 396 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-18
• Study Completion Date: 2025-06-03

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Aquacel dressing

Intervention Type: DEVICE

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.

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.

Group Type: OTHER

Aquacel dressing

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Vasili Karas

Assistant Professor, Orthopaedic Surgery Adult Reconstruction and Replacement

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vasili Karas, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

23050308

Identifier Type: -

Identifier Source: org_study_id