Status:
COMPLETED
Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty
Lead Sponsor:
The Cleveland Clinic
Conditions:
Wound Heal
Eligibility:
All Genders
18-80 years
Phase:
NA
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 clos...
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 s...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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- Has an uncontrolled illness that, in the opinion of the investigator, is likely to cause the patient to be withdrawn from the trial or would otherwise interfere with interpreting the results of the study.
Key Trial Info
Start Date :
September 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03285542
Start Date
September 15 2017
End Date
June 30 2019
Last Update
May 13 2021
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195