Trial Outcomes & Findings for Aquacel Hypersensitivity Dressing in TJAs (NCT NCT06011629)
NCT ID: NCT06011629
Last Updated: 2026-08-04
Results Overview
Using a classification of skin reactions from mild, moderate to severe
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
457 participants
Primary outcome timeframe
14 days post surgery
Results posted on
2026-08-04
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
280
|
177
|
|
Overall Study
COMPLETED
|
280
|
177
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arthroplasty-naïve Aquacel Group
n=280 Participants
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.
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.
|
Prior Aquacel Group
n=177 Participants
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.
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.
|
Total
n=457 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=280 Participants
|
0 Participants
n=177 Participants
|
0 Participants
n=457 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
169 Participants
n=280 Participants
|
106 Participants
n=177 Participants
|
275 Participants
n=457 Participants
|
|
Age, Categorical
>=65 years
|
111 Participants
n=280 Participants
|
71 Participants
n=177 Participants
|
182 Participants
n=457 Participants
|
|
Age, Continuous
|
62.2 year
STANDARD_DEVIATION 9.3 • n=280 Participants
|
63.6 year
STANDARD_DEVIATION 7.8 • n=177 Participants
|
62.7 year
STANDARD_DEVIATION 8.8 • n=457 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=280 Participants
|
93 Participants
n=177 Participants
|
231 Participants
n=457 Participants
|
|
Sex: Female, Male
Male
|
142 Participants
n=280 Participants
|
84 Participants
n=177 Participants
|
226 Participants
n=457 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
280 participants
n=280 Participants
|
177 participants
n=177 Participants
|
457 participants
n=457 Participants
|
PRIMARY outcome
Timeframe: 14 days post surgeryUsing a classification of skin reactions from mild, moderate to severe
Outcome measures
| Measure |
Arthroplasty-naïve Aquacel Group
n=280 Participants
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.
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.
|
Prior Aquacel Group
n=177 Participants
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.
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
|
5 Participants
|
3 Participants
|
Adverse Events
Prior Aquacel Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arthroplasty-naïve Aquacel Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Anne DeBenedetti, MSc, clinical research manager
Rush University Medical Center
Phone: 3124322468
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place