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
Wound complications
Any workup for PJI (Serologic labs (ESR/CRP), arthrocentesis)
Any administration of post-operative antibiotics outside of normal protocol
Return to Operating Room for debridement, manipulation, other surgical interventions
Surgical Site Infection (SSI)
Confirmed Periprosthetic Joint Infection (PJI)
Stiffness requiring Manipulation Under Anesthesia (MUA)