A Phase 4 interventional study of Aquacel dressing in Contact Allergic Dermatitis and Adverse Skin Reaction, sponsored by Rush University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Rush University Medical Center · Phase 4, Interventional, and Prevention
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.
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
50 studies on the registry are indexed under Dermatitis, Allergic Contact; 11 are open to participants now.
This study's enrollment of 457 is above the median of 48 across 38 interventional studies indexed under Dermatitis, Allergic Contact.
Browse Dermatitis, Allergic Contact studies →Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Number of Participants With Contact Allergic Dermatitis or Adverse Skin Reaction at 2 Weeks Post Surgery
Using a classification of skin reactions from mild, moderate to severe
Time frame: 14 days post surgery
| Milestone | Arthroplasty-naïve Aquacel Group | Prior Aquacel Group |
|---|---|---|
| Started | 280 | 177 |
| Completed | 280 | 177 |
| Not completed | 0 | 0 |
Using a classification of skin reactions from mild, moderate to severe
| Participants | Arthroplasty-naïve Aquacel Group | Prior Aquacel Group |
|---|---|---|
| Number of Participants With Contact Allergic Dermatitis or Adverse Skin Reaction at 2 Weeks Post Surgery | 5 | 3 |
Collected over 90 days after surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prior Aquacel Group | 0/177 (0%) | 0/177 (0%) | 0/177 (0%) |
| Arthroplasty-naïve Aquacel Group | 0/280 (0%) | 0/280 (0%) | 0/280 (0%) |
| Age, Categorical(Participants) | Arthroplasty-naïve Aquacel Group | Prior Aquacel Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 169 | 106 | 275 |
| >=65 years | 111 | 71 | 182 |
| Age, Continuous(year) | Arthroplasty-naïve Aquacel Group | Prior Aquacel Group | Total |
|---|---|---|---|
| Mean | 62.2 ± 9.3 | 63.6 ± 7.8 | 62.7 ± 8.8 |
| Sex: Female, Male(Participants) | Arthroplasty-naïve Aquacel Group | Prior Aquacel Group | Total |
|---|---|---|---|
| Female | 138 | 93 | 231 |
| Male | 142 | 84 | 226 |
| Race and Ethnicity Not Collected(Participants) | Arthroplasty-naïve Aquacel Group | Prior Aquacel Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Arthroplasty-naïve Aquacel Group | Prior Aquacel Group | Total |
|---|---|---|---|
| United States | 280 | 177 | 457 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Once complete, we will share the summary of the data along with study protocol and SAP
Supporting information: Study protocol, Sap
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Rush University Medical Center