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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 is a Phase 4 study that has completed, run by Rush University Medical Center. The registered enrollment target is 303 participants.

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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.

Interventions

  • DEVICE Prineo dressing

Trial Details

FieldValue
Enrollment Target 303 participants
Start Date 2023-08-17
Est. Completion 2024-11-30
Phase Phase 4

Sponsor

Rush University Medical Center

320 total trials

What the Registry Record Tells You About NCT06011603

The ClinicalTrials.gov registry entry for NCT06011603 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 303 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Prineo dressing is the first listed.

NCT06011603 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.