Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty

The DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system is a
unique two-part skin closure system that consists of: a 2-octyl cyanoacrylate topical skin
adhesive for proven strength and microbial protection in vitro, and a flexible, self-adhesive
polyester mesh for excellent approximation and healing. It is aimed to add strength and
protection when closing medium to long incisions. In addition, it is designed to replace the
use of subcuticular sutures or staples, with greater holding strength, with the potential to
reduce skin closure time.

Various studies have evaluated the outcomes of different closure devices, however, there are
no reports assessing the length of closure times using DERMABOND PRINEO (Ethicon, Johnson and
Johnson, Somerville, New Jersey) Knotless Tissue Control Devices during superficial closure
in orthopaedic surgery. Huemer et al. (1) performed an observational study of 180 patients
who had 224 excisional body-contouring surgeries utilizing Dermabond Prineo for superficial
closure. Authors concluded that this closure type enables the surgeon to perform a quick and
smooth skin closure. However, 4 patients (1.8%) developed local allergic reactions, which
necessitated early removal and topical corticosteroid treatment. Parvizi et al.(2) performed
an open, prospective, randomized clinical study of superficial wound closure on 60 patients
undergoing abdominoplasty with either Dermabond Prineo or conventional superficial closure.
They found significantly lower price ($134.79 cheaper) and significantly better Hollander
Cosmesis Scale scores in Dermabond Prineo cohort. In addition, there was a significantly
better cosmetic outcome at 6 and 12 months after surgery. The use of Dermabond Prineo may be
able to decrease operative time and costs in other surgical fields, such as orthopedics.
Careful patient allergy history is necessary to avoid adhesive allergic reactions.

Inclusion Criteria:

1. Males and females, between the ages of 18 to 80 years at the time of signing the
informed consent document.

2. Understand and voluntarily sign an informed consent document prior to any
study-related assessments/procedures are conducted.

3. Able to adhere to the study visit schedule and other protocol requirements.

4. Able to fluently speak and understand the local language

5. If female, is nonpregnant (negative pregnancy test results at the
baseline/randomization visit) and nonlactating.

6. End-stage osteoarthritis patients planning to undergo primary total knee arthroplasty

7. BMI less than 40 kg/m2

Exclusion Criteria:

1. BMI greater than or equal to 40 kg/m2

2. History of known bleeding disorder

3. History of medical co-morbidity that may result in poor wound healing (ie. diabetes
mellitus, peripheral vascular disease)

4. Patients <18 or >80 years of age

5. Patients who are prisoners

6. Mentally unable to sign informed consent

7. Has an uncontrolled illness that, in the opinion of the investigator, is likely to
cause the patient to be withdrawn from the trial or would otherwise interfere with
interpreting the results of the study.