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: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines allergic reactions to a specific wound dressing called Prineo, used after joint replacement surgeries. It compares individuals who have previously used Prineo to those who have not, assessing the development of skin issues like redness or an itchy rash. The goal is to determine if prior exposure to Prineo influences the likelihood of these reactions. Individuals who have undergone total hip or knee replacement and have not experienced allergic skin reactions before may be suitable for this trial. As a Phase 4 trial, Prineo is already FDA-approved and proven effective, and this research aims to understand its benefits for more patients.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for the Prineo dressing?

Research has shown that the Prineo dressing, made from a type of surgical glue, rarely causes skin reactions. In one study, only about 0.5% of patients experienced skin reactions after surgeries using this dressing. However, some individuals have reported allergic reactions, such as redness and blisters, especially if they have previously used this type of dressing.

Another study found no allergic reactions when comparing Prineo to traditional stitches, suggesting that while allergic reactions can occur, they are uncommon. Prineo is already used in medical settings, indicating it is generally considered safe. Those considering joining a trial that uses Prineo should discuss any allergies with their doctor. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Prineo dressing because it offers a potentially less allergenic option for wound care after surgeries like joint replacements. Unlike traditional dressings that might cause allergic reactions due to their materials or adhesives, Prineo uses a unique glue/mesh combination that could be more skin-friendly. This dressing is particularly interesting because it might reduce post-surgical complications related to allergies, making the healing process smoother and more comfortable for patients.

What evidence suggests that the Prineo dressing is effective for minimizing wound complications?

Research shows that Prineo dressings can reduce wound infections and speed up healing after surgery. Studies have found that these dressings lower infection rates and help wounds heal faster. However, some people may experience skin reactions, such as redness or a rash, with about 0.5% of users experiencing these reactions after orthopedic surgeries. This trial will compare two groups: the Prineo-exposed group, consisting of participants with previous exposure to Prineo dressings, and the Prineo-naive group, consisting of participants without prior exposure. Repeated use might slightly increase the risk of allergic reactions, suggesting that previous exposure could lead to more allergies. Overall, Prineo dressings effectively aid wound healing, but there's a small chance of allergic reactions. ^{1 6 7 8 9}

Who Is on the Research Team?

Vasili Karas, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I am scheduled for or have had revision surgery.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Application of Prineo dressing during total joint arthroplasty surgery

1 day

1 visit (in-person)

Initial Follow-up

Assessment of allergic reactions and wound complications at 1 week post-surgery

1 week

1 visit (in-person or virtual)

Secondary Follow-up

Further assessment of allergic reactions and wound complications at 2-3 weeks post-surgery

2-3 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40047817/

Dermabond Prineo: a systematic review and meta-analysis In this review, Dermabond Prineo showed lower wound infection rates and a reduction in delayed wound healing. Further studies are required ...

2. trialx.com trialx.com/clinical-trials/listings/220599/prineo-sensitivity-dressing-study/

Prineo Sensitivity Dressing Study | Clinical Research Trial ... The study team feel an increase in allergic reaction from 1% in Prineo naive patients to 2% in patients with previous Prineo use will be ...

3. jnjmedtech.com jnjmedtech.com/sites/default/files/user_uploaded_assets/pdf_assets/2020-10/DERMABOND%20PRINEO%20Dermatitis%20Study%20Stat%20130875-200120.pdf

DERMABOND® PRINEO® - Study Stats CONCLUSION. Skin reactions to DERMABOND PRINEO System occur in an estimated 0.5% of cases when used following orthopedic operations.

4. jss.amegroups.org jss.amegroups.org/article/view/6100/html

Allergic contact dermatitis to Dermabond Prineo after ... This case study shows that cyanoacrylates can act as an allergen. Delayed and repeated exposure to Dermabond Prineo can cause allergic contact dermatitis.

5. liebertpub.com liebertpub.com/doi/10.1089/gyn.2023.0038

The Dermabond Prineo Skin Closure System: Benefits and ... DP is safe, according to various studies. It has many advantages, such as cost and operating-time reduction, better cosmetic results, and-more-hygienic ...

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8772882&pc=OMD

ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE Patient had allergy and blistering after using adhesive as closure and wound dressing.The redness and allergy mainly resides along the shape ...

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=11558842&pc=OMD

MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN ... Did the event occur during one or multiple patient procedures? prineo reactions have increasingly gotten worse for our patients.We have taken it off post-op day ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2015/642595

Rash with DERMABOND PRINEO Skin Closure System ... One study comparing sutures to DERMABOND PRINEO Skin Closure System in patients did not report any allergic reactions [3]. In a retrospective ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32882052/

Allergic Contact Dermatitis to Dermabond Prineo After ... Patch testing showed positive reactions to Dermabond Prineo glue for all patients. Orthopedic surgeons should be aware of the potential for ACD ...