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NCT06011603 · ClinicalTrials.gov registry record · Phase 4
Prineo Sensitivity Dressing Study
A Phase 4 study, sponsored by Rush University Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 303
- Enrollment target
NCT06011603: Completed Phase 4 study, sponsored by Rush University Medical Center.
NCT06011603 is a Phase 4 study that has completed, run by Rush University Medical Center. The registered enrollment target is 303 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06011603, a Phase 4 study, has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 303 participants
- Enrollment target
Study Summary
Wound complications can be devastating following total joint arthroplasty, resulting in an increased practice burden in the form of more frequent follow ups, increased clinic visits potential for wound dehiscence, superficial infection and deep infection with possible return to the operating room and revision surgery. Several dressing options are currently on the market designed to minimize wound complications in addition to traditional dressings, including negative pressure dressing, antimicrobial dressing, occlusive dressings, and/or skin adhesives. Prineo dressing (2-octyl cyanoacrylate adhesive (Dermabond) and n-butyl-2-cyanoacrylate adhesive) has increased in popularity as a dressing option used by joint arthroplasty surgeons. There is a well-documented adverse allergic response with these dressings resulting in peri-incisional erythema, urticaria, and/or an eczematous skin reaction. Recently, Mayman et al reported a rate of 1-1.5%, suggesting a possible rising incidence of ACD attributable to increased utilization of the specific dressing and sensitization. To our knowledge, no prospective trial has compared the rates of adverse allergic reactions in Prineo naive patients to patients who have undergone previous total joint arthroplasty (TJA) and received Prineo dressings in the past. The study team will utilize a prospective controlled study design to assess the rate of adverse allergic reactions in patients naive to Prineo versus those with previous exposure. The study team will assess rates of allergic reactions at one week post-op and at their first post-op clinic visit, 2 to 3 weeks post-op, tracking rates of allergic reactions as well as severity, the use of post-operative antibiotics, work up for prosthetic joint infection, return to the operating room, surgical site infection, confirmed prosthetic joint infection and stiffness requiring manipulation under anesthesia.
Primary Outcome
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
Interventions
- DEVICE Prineo dressing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2023-08-17 |
| Est. Completion | 2024-11-30 |
| Phase | Phase 4 |
What the finished NCT06011603 record still lists
NCT06011603 is an interventional study that assigns participants to a tested intervention. The registered 303 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 1 intervention - of which Prineo dressing is the first listed.
NCT06011603 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06011603 about?
NCT06011603 is a clinical study titled "Prineo Sensitivity Dressing Study". Wound complications can be devastating following total joint arthroplasty, resulting in an increased practice burden in the form of more frequent follow ups, increased clinic visits potential for wound dehiscence, superficial infection and deep infection with possible return to the operating room an...
What is the current status of trial NCT06011603?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 303 participants. The study started on 2023-08-17. Estimated completion is 2024-11-30.
What interventions are being tested in trial NCT06011603?
The interventions under investigation include: Prineo dressing (DEVICE).
Who is sponsoring clinical trial NCT06011603?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06011603's enrollment target sits among peer trials
303 266th of 2000 higher than 1,735 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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