N/A
N=60
Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty
Wound Heal
Bottom Line
View on ClinicalTrials.gov: NCT03285542 ↗Enrolled (actual)
60
Serious AEs
3.3%
Results posted
Nov 2020
Primary outcome: Primary: Modified Hollander Cosmesis Scale — 30; 0; 0; 23 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DERMABOND (Device); Staples (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Hollander Cosmesis Scale |
30; 0; 0; 23; 0; 5 | — |
| SECONDARY Number of Patients With Wound Complications |
2; 0 | — |
| SECONDARY Patient Satisfaction (Visual Analogue Scale) |
97.6; 82.6 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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 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- Has an uncontrolled illness that, in the opinion of the investigator, is likely to cause the patient to be withdrawn from the trial or would otherwise interfere with interpreting the results of the study.
Data sourced from ClinicalTrials.gov (NCT03285542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.