Clinical trial NCT06011629: Aquacel Hypersensitivity Dressing in TJAs
Official title: Prospective Evaluation of Type IV Hypersensitivity Reactions After Aquacel Dressing Application in Partial and Total Joint Arthroplasty Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Contact Allergic Dermatitis
Adverse Skin Reaction
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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)

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

Primary outcomes:
measure: Rate of contact allergic dermatitis or adverse skin reaction at 1 week post surgery
timeFrame: 7 days post surgery
measure: Rate of contact allergic dermatitis or adverse skin reaction at 2-3 weeks post surgery
timeFrame: 2-3 weeks following surgery
Secondary outcomes:
measure: Wound complications (if applicable)
timeFrame: 1 week post surgery
measure: Wound complications (if applicable)
timeFrame: 2-3 weeks after surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Vasili Karas, MD
role: PRINCIPAL_INVESTIGATOR
References: