NCT03285542

Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty

Prospective Randomized Trial of Dermabond Prineo Wound Closure System on Operating Room Time and Wound Closure Time in Total Knee Arthroplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In this prospective pilot study examining the superficial closure during total knee arthroplasty, active subjects will receive the STRATAFIX Spiral Knotless Tissue Control Device for subcuticular closure in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure. The control subjects will receive staples (standard-of-care).

Detailed description

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.

Conditions

• Wound Heal

Interventions

Type	Name	Description
DEVICE	DERMABOND	DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)
DEVICE	Staples	staples for skin closure

Timeline

• Start date: 2017-09-15
• Primary completion: 2019-03-25
• Completion: 2019-06-30
• First posted: 2017-09-18
• Last updated: 2021-05-13
• Results posted: 2020-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study