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NCT03285542 · ClinicalTrials.gov registry record · NA
Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty
A NA study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT03285542: Completed NA study, sponsored by The Cleveland Clinic.
NCT03285542 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03285542, a NA study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study 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).
Primary Outcome
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;
Interventions
- DEVICE Staples
- DEVICE DERMABOND
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-09-15 |
| Est. Completion | 2019-06-30 |
| Phase | NA |
What the finished NCT03285542 record still lists
NCT03285542 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Staples is the first listed.
NCT03285542 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03285542 about?
NCT03285542 is a clinical study titled "Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty". 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 fo...
What is the current status of trial NCT03285542?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2017-09-15. Estimated completion is 2019-06-30.
What interventions are being tested in trial NCT03285542?
The interventions under investigation include: Staples (DEVICE), DERMABOND (DEVICE).
Who is sponsoring clinical trial NCT03285542?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03285542's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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