Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty

NCT03285542 | Completed Results FDA Device

• 1 other identifier: 17-842
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Wound Heal

Keywords

adhesive; total knee arthroplasty; wound; closure; time; barbed suture; knoteless suture

Outcome Measures

Primary Outcomes (1)

• Modified Hollander Cosmesis Scale

  Scar evaluation scale is used to assess the long-term aesthetic or cosmetic appearance of scars. Scars were assigned 0 or 1 point each for the presence (1) or absence (0) of the following: (1) a width greater than 2 mm at any point of the scar; (2) a raised or depressed scar in relation to the surrounding normal skin; (3) red, blue, brown, or black discoloration of the scar relative to the surrounding normal skin; (4) any hatch marks on either side of the scar from previous sutures or staples; and (5) overall poor or ugly appearance. The total score was then derived by adding the scores on the individual items of the scar evaluation scale ranging from 0 (best) to 5 (worst).

  90 days postoperative

Secondary Outcomes (2)

• Number of Patients With Wound Complications

  90 days postoperative

• Patient Satisfaction (Visual Analogue Scale)

  90 days postoperative

Study Arms (2)

DERMABOND GROUP

ACTIVE COMPARATOR

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.

Device: DERMABOND

CONTROL GROUP

PLACEBO COMPARATOR

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

Device: Staples

Interventions

DERMABOND DEVICE

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

DERMABOND GROUP

Staples DEVICE

staples for skin closure

CONTROL GROUP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, between the ages of 18 to 80 years at the time of signing the informed consent document.
• Understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures are conducted.
• Able to adhere to the study visit schedule and other protocol requirements.
• Able to fluently speak and understand the local language
• If female, is nonpregnant (negative pregnancy test results at the baseline/randomization visit) and nonlactating.
• End-stage osteoarthritis patients planning to undergo primary total knee arthroplasty
• BMI less than 40 kg/m2

You may not qualify if:

• BMI greater than or equal to 40 kg/m2
• History of known bleeding disorder
• History of medical co-morbidity that may result in poor wound healing (ie. diabetes mellitus, peripheral vascular disease)
• Patients \<18 or \>80 years of age
• Patients who are prisoners
• Mentally unable to sign informed consent
• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Viktor Krebs
• Organization: Cleveland Clinic

krebsv@ccf.org

216-445-3843

Study Officials

• Viktor Krebs, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chairman - Adult Reconstruction

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 18, 2017
• Study Start: September 15, 2017
• Primary Completion: March 25, 2019
• Study Completion: June 30, 2019
• Last Updated: May 13, 2021
• Results First Posted: November 24, 2020

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)