Prineo Dressing Sensitivity for Allergy

Overseen By Conor Jones, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rush University Medical Center

Disqualifiers: Revision surgery, allergic contact dermatitis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

236 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Vasili Karas, MD

Principal Investigator

Rush University Medical Center

Eligibility Criteria

This trial is for patients over 18 years old who have had a primary total joint replacement (hip, knee, or partial knee) and haven't used Prineo dressing before. It's not for those with a history of allergic skin reactions or who need revision surgery.

Inclusion Criteria

I am over 18 and had a hip or knee replacement surgery.

Exclusion Criteria

You have had a skin allergy in the past called allergic contact dermatitis.

I am scheduled for or have had revision surgery.

Treatment Details

Interventions

• Prineo dressing

Trial Overview The study tests if there's a difference in allergic reactions to Prineo dressings between first-time users and those who've had it before after joint replacement surgery. The reaction rates are checked one week post-op and at the first clinic visit, 2-3 weeks later.

Participant Groups

Group I: Prineo-exposed group Experimental Treatment 1 Intervention

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.

Group II: Prineo naive group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+