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Clinical Trial

Prineo Sensitivity Dressing Study

NCT: NCT06011603 · COMPLETED

NCT IDNCT06011603
StatusCOMPLETED
Start Date2023-08-17
Completion2024-11-30
SponsorRush University Medical Center (OTHER)
First posted
Last updated

Brief 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.

Frequently Asked Questions

What is Prineo Sensitivity Dressing Study?

Prineo Sensitivity Dressing Study is a clinical trial registered under NCT06011603. Current status: COMPLETED.

What is the status of NCT06011603?

The current status of NCT06011603 (Prineo Sensitivity Dressing Study) is: COMPLETED.

When did Prineo Sensitivity Dressing Study start?

Prineo Sensitivity Dressing Study started on 2023-08-17.

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Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.