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Completed Phase 4 Interventional Accepts healthy volunteers Results available

Prineo Sensitivity Dressing Study

ClinicalTrials.gov ID: NCT06011603

Public ClinicalTrials.gov record NCT06011603. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 11:05 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Prospective Evaluation of Type IV Hypersensitivity Reactions After Prineo Dressing Application in Partial and Total Joint Arthroplasty Patients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06011603
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Enrollment
303 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 16, 2023
Primary completion
Oct 31, 2024
Completion
Nov 29, 2024
Last update posted
Jul 9, 2026

2023 – 2024

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Rush University Medical Center Chicago Illinois 60612

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06011603, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 9, 2026 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06011603 live on ClinicalTrials.gov.

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