Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty

NCT03285542 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-05-13

Study results available
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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

Interventions

DEVICE

DERMABOND

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

DEVICE

Staples

staples for skin closure

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Viktor Krebs, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2019-03-25
Completion
2019-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03285542 on ClinicalTrials.gov