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NCT04409093 · ClinicalTrials.gov registry record · NA
Eponychial Stent Study
A NA study of Eponychial Stent and Nail Bed Injury, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 54
- Enrollment target
- 3
- Study locations
NCT04409093 is a NA study of Eponychial Stent and Nail Bed Injury that has completed, run by NYU Langone Health. The registered enrollment target is 54 participants. The trial reports 3 study locations across 1 state.
The verdict
NCT04409093, a NA study of Eponychial Stent and Nail Bed Injury, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 54 participants
- Enrollment target
- 3
- Study locations
Study Summary
The study design is a prospective, randomized, controlled trial evaluating the cosmetic and functional outcomes of nail bed repairs with and without eponychial stents. Patients presenting to a single institution with a finger tip injury requiring a nail bed repair will be initially evaluated in the emergency department. The purpose of the study will be explained to the patient, and informed consent for participation will be obtained. Patients will be randomly assigned to either the eponychial stent or no eponychial stent group based on the last digit of their assigned medical record number. Even-numbered patients will be randomized to the stent group and odd-numbered patients will be randomized to the no stent group. Demographic data will be obtained and recorded (age, gender, hand dominance, mechanism of injury, and past medical history). All patients will undergo a thorough clinical exam under digital nerve block followed by removal of the nail plate and thorough irrigation and debridement of devitalized tissue. The nail bed repair will be performed with 6-0 chromic suture material. After the nail bed repair, a stent (native nail, suture container foil, or nonadherent gauze) will or will not secured under the eponychial fold with suture depending on randomization. Laceration characteristic and time required to perform the procedure will be recorded. A nonadherent sterile dressing will be applied to the digit, and each patient will be discharged with a 5-day course of cephalexin for prophylaxis against infection. Follow-up evaluation will occur at 1 week, 1 month, 3 months, and 6 months. A each follow-up visit, patient-perceived functional outcome, cosmetic outcome, and level of pain will be assessed using a 10-point analog scale. Cosmetic results will also be evaluated by the examining physician using a validated physician-based outcome tool.
Conditions Studied
Interventions
- PROCEDURE Nail bed repair with eponychial sent
- PROCEDURE Nail bed repair without eponychial stent
Study Locations (3)
New York
- NYU Langone Orthopedic Hospital - New York
- Tisch Hospital, NYU Langone Health - New York
- Jamaica Hospital Medical Center - Richmond Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2023-08-24 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04409093
The ClinicalTrials.gov registry entry for NCT04409093 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Eponychial Stent appearing as the primary indexed condition, and to 2 interventions - of which Nail bed repair with eponychial sent is the first listed.
NCT04409093 reports 3 study locations spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT04409093 about?
NCT04409093 is a clinical study titled "Eponychial Stent Study". The study design is a prospective, randomized, controlled trial evaluating the cosmetic and functional outcomes of nail bed repairs with and without eponychial stents. Patients presenting to a single institution with a finger tip injury requiring a nail bed repair will be initially evaluated in the ...
What is the current status of trial NCT04409093?
This trial is currently completed. It is a NA study. The enrollment target is 54 participants. The study started on 2020-06-01. Estimated completion is 2023-08-24.
What conditions does trial NCT04409093 study?
This clinical trial studies the following conditions: Eponychial Stent, Nail Bed Injury.
What interventions are being tested in trial NCT04409093?
The interventions under investigation include: Nail bed repair with eponychial sent (PROCEDURE), Nail bed repair without eponychial stent (PROCEDURE).
Who is sponsoring clinical trial NCT04409093?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04409093 being conducted?
This trial has 3 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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