Trial Outcomes & Findings for Prineo Sensitivity Dressing Study (NCT NCT06011603)
NCT ID: NCT06011603
Last Updated: 2026-07-10
Results Overview
Using a classification of skin reactions from mild, moderate to severe- Rate of contact allergic dermatitis or adverse skin reaction at 1 week post surgery
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
303 participants
Primary outcome timeframe
7 days post surgery
Results posted on
2026-07-10
Participant Flow
Participant milestones
| Measure |
Prineo Naive Group
All subject's receive the same dressing, this group is comprised of patients consented to the study and will receive the Prineo dressing but have not had previous joint replacement surgery. Therefore, we consider them Prineo-naive.
Prineo dressing: Prineo dressing is a common dressing option used in Joint Arthroplasty surgery. It is an adhesive dressing growing in popularity that is thought to lead to reinforced tension across the wound while also decreasing the skin edge ischemia.
|
Prineo-exposed Group
All subject's receive the Prineo dressing, this group is comprised of patients who have undergone previous joint replacement surgery (hip or knee) and have had a prineo dressing. This also includes patients who have had prior exposure to glue/mesh dressing either as a patient or healthcare worker.
Prineo dressing: Prineo dressing is a common dressing option used in Joint Arthroplasty surgery. It is an adhesive dressing growing in popularity that is thought to lead to reinforced tension across the wound while also decreasing the skin edge ischemia.
|
|---|---|---|
|
Overall Study
STARTED
|
208
|
95
|
|
Overall Study
COMPLETED
|
208
|
95
|
|
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 |
Prineo Naive Group
n=208 Participants
All subject's receive the same dressing, this group is comprised of patients consented to the study and will receive the Prineo dressing but have not had previous joint replacement surgery. Therefore, we consider them Prineo-naive.
Prineo dressing: Prineo dressing is a common dressing option used in Joint Arthroplasty surgery. It is an adhesive dressing growing in popularity that is thought to lead to reinforced tension across the wound while also decreasing the skin edge ischemia.
|
Prineo-exposed Group
n=95 Participants
All subject's receive the Prineo dressing, this group is comprised of patients who have undergone previous joint replacement surgery (hip or knee) and have had a prineo dressing. This also includes patients who have had prior exposure to glue/mesh dressing either as a patient or healthcare worker.
Prineo dressing: Prineo dressing is a common dressing option used in Joint Arthroplasty surgery. It is an adhesive dressing growing in popularity that is thought to lead to reinforced tension across the wound while also decreasing the skin edge ischemia.
|
Total
n=303 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=208 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=303 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
122 Participants
n=208 Participants
|
57 Participants
n=95 Participants
|
179 Participants
n=303 Participants
|
|
Age, Categorical
>=65 years
|
86 Participants
n=208 Participants
|
38 Participants
n=95 Participants
|
124 Participants
n=303 Participants
|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 9.7 • n=208 Participants
|
64.3 years
STANDARD_DEVIATION 8.6 • n=95 Participants
|
63.6 years
STANDARD_DEVIATION 9.4 • n=303 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=208 Participants
|
45 Participants
n=95 Participants
|
155 Participants
n=303 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=208 Participants
|
50 Participants
n=95 Participants
|
148 Participants
n=303 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 7 days post surgeryUsing a classification of skin reactions from mild, moderate to severe- Rate of contact allergic dermatitis or adverse skin reaction at 1 week post surgery
Outcome measures
| Measure |
Prineo Naive Group
n=208 Participants
All subject's receive the same dressing, this group is comprised of patients consented to the study and will receive the Prineo dressing but have not had previous joint replacement surgery. Therefore, we consider them Prineo-naive.
Prineo dressing: Prineo dressing is a common dressing option used in Joint Arthroplasty surgery. It is an adhesive dressing growing in popularity that is thought to lead to reinforced tension across the wound while also decreasing the skin edge ischemia.
|
Prineo-exposed Group
n=95 Participants
All subject's receive the Prineo dressing, this group is comprised of patients who have undergone previous joint replacement surgery (hip or knee) and have had a prineo dressing. This also includes patients who have had prior exposure to glue/mesh dressing either as a patient or healthcare worker.
Prineo dressing: Prineo dressing is a common dressing option used in Joint Arthroplasty surgery. It is an adhesive dressing growing in popularity that is thought to lead to reinforced tension across the wound while also decreasing the skin edge ischemia.
|
|---|---|---|
|
Number of Participants With Contact Allergic Dermatitis or Adverse Skin Reaction at 1 Week Post Surgery
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Rate of contact allergic dermatitis or adverse skin 2-3 weeks following surgeryUsing a classification of skin reactions from mild, moderate to severe
Outcome measures
| Measure |
Prineo Naive Group
n=208 Participants
All subject's receive the same dressing, this group is comprised of patients consented to the study and will receive the Prineo dressing but have not had previous joint replacement surgery. Therefore, we consider them Prineo-naive.
Prineo dressing: Prineo dressing is a common dressing option used in Joint Arthroplasty surgery. It is an adhesive dressing growing in popularity that is thought to lead to reinforced tension across the wound while also decreasing the skin edge ischemia.
|
Prineo-exposed Group
n=95 Participants
All subject's receive the Prineo dressing, this group is comprised of patients who have undergone previous joint replacement surgery (hip or knee) and have had a prineo dressing. This also includes patients who have had prior exposure to glue/mesh dressing either as a patient or healthcare worker.
Prineo dressing: Prineo dressing is a common dressing option used in Joint Arthroplasty surgery. It is an adhesive dressing growing in popularity that is thought to lead to reinforced tension across the wound while also decreasing the skin edge ischemia.
|
|---|---|---|
|
Rate of Contact Allergic Dermatitis or Adverse Skin 2-3 Weeks Following Surgery
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 90 days post surgeryIf patients present with wound complications, require possible work up for infection, require antibiotics outside of normal protocol due to concerns of infection, return to the operating room, confirmed periprosthetic joint infection or stiffness that requires a manipulation under anesthesia
Outcome measures
| Measure |
Prineo Naive Group
n=208 Participants
All subject's receive the same dressing, this group is comprised of patients consented to the study and will receive the Prineo dressing but have not had previous joint replacement surgery. Therefore, we consider them Prineo-naive.
Prineo dressing: Prineo dressing is a common dressing option used in Joint Arthroplasty surgery. It is an adhesive dressing growing in popularity that is thought to lead to reinforced tension across the wound while also decreasing the skin edge ischemia.
|
Prineo-exposed Group
n=95 Participants
All subject's receive the Prineo dressing, this group is comprised of patients who have undergone previous joint replacement surgery (hip or knee) and have had a prineo dressing. This also includes patients who have had prior exposure to glue/mesh dressing either as a patient or healthcare worker.
Prineo dressing: Prineo dressing is a common dressing option used in Joint Arthroplasty surgery. It is an adhesive dressing growing in popularity that is thought to lead to reinforced tension across the wound while also decreasing the skin edge ischemia.
|
|---|---|---|
|
Number of Participants With Post Operative Complications
|
38 Participants
|
12 Participants
|
Adverse Events
Prineo Naive Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 38 deaths
Prineo-exposed Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 12 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place