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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: Completed NA study of Eponychial Stent and Nail Bed Injury, sponsored by NYU Langone Health.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Mean score from all time points 0 = complete loss of affected digit function during activities of daily living and recreational activities 10 = no functional limitation
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 |
What the finished NCT04409093 record still lists
NCT04409093 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 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 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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04409093's enrollment target sits among peer trials
54 1268th of 2000 higher than 730 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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