Prineo Sensitivity Dressing Study

NCT06011603 | Completed Phase 4 FDA Device

• 1 other identifier: 23041601
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Reaction; Wound Complication

Outcome Measures

Primary Outcomes (2)

• Rate of contact allergic dermatitis or adverse skin reaction at 1 week post surgery

  Using a classification of skin reactions from mild, moderate to severe

  7 days post surgery

• Rate of contact allergic dermatitis or adverse skin reaction at 2-3 weeks post surgery

  Using a classification of skin reactions from mild, moderate to severe

  2-3 weeks following surgery

Secondary Outcomes (2)

• Wound complications (if applicable)

  1 week post surgery

• Wound complications (if applicable)

  2-3 weeks after surgery

Study Arms (2)

Prineo naive group

OTHER

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.

Device: Prineo dressing

Prineo-exposed group

OTHER

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.

Device: Prineo dressing

Interventions

Prineo dressing DEVICE

Prineo dressing is a common dressing option used in Joint Arthroplasty surgery. It is an adhesive dressing growing in popularity that is thought to lead to reinforced tension across the wound while also decreasing the skin edge ischemia.

Prineo naive group; Prineo-exposed group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years that underwent primary total joint arthroplasty (total hip, total knee, partial knee)

You may not qualify if:

• Revision surgery
• Prior history of allergic contact dermatitis

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Vasili Karas, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Orthopaedic Surgery Adult Reconstruction and Replacement

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 25, 2023
• Study Start: August 17, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 30, 2024
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Once the study is fully enrolled

Locations

US (1)