Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty

NCT ID: NCT03285542

Last Updated: 2021-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-15
• Study Completion Date: 2019-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DERMABOND GROUP

For the active arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a STRATAFIX Spiral Knotless Tissue Control Device in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure.

Group Type: ACTIVE_COMPARATOR

DERMABOND

Intervention Type: DEVICE

DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)

CONTROL GROUP

For the control arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by skin closure with staples

Group Type: PLACEBO_COMPARATOR

Staples

Intervention Type: DEVICE

staples for skin closure

Interventions

DERMABOND

DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)

Intervention Type: DEVICE

Staples

staples for skin closure

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Viktor Krebs, M.D.

Vice Chairman - Adult Reconstruction

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Viktor Krebs, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-842

Identifier Type: -

Identifier Source: org_study_id