Clinical trial NCT04409093: Eponychial Stent Study
Official title: A Prospective, Randomized, Controlled Trial Evaluating the Utility of Eponychial Stents for Nail Re-growth in Nail Bed Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eponychial Stent
Nail Bed Injury
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion criteria:

1. Men and women, age \> 18 years.
2. Patients with either nail plate avulsion and/or fracture with associated nail bed injury or subungal hematoma \> 50% with intact nail plate.
3. Presentation within 8 hours of injury.
4. Being treated at NYU Langone Health or Jamaica Hospital Medical Center.
5. Willingness to participate in the study

Exclusion criteria:

1. Nail plate/bed injury secondary to bite wound

Primary outcomes:
measure: Patient reported score on functional outcome scale (10-point analog scale)
timeFrame: after procedure: 1 week, 1 month, 3 months, and 6 months
measure: Patient reported score on cosmetic outcome scale (10-point analog scale)
timeFrame: after procedure: 1 week, 1 month, 3 months, and 6 months
measure: Patient reported pain level on Visual Analog Scale (VAS)
timeFrame: after procedure: 1 week, 1 month, 3 months, and 6 months
measure: Physician reported cosmetic outcome
timeFrame: after procedure: 1 week, 1 month, 3 months, and 6 months
Secondary outcomes:
measure: Procedure time
timeFrame: 0-1 hour
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Orthopedic Hospital
state: New York
city: New York
country: United States
facility: Tisch Hospital, NYU Langone Health
state: New York
city: Richmond Hill
country: United States
facility: Jamaica Hospital Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Nader Paksima, DO MPH
role: PRINCIPAL_INVESTIGATOR
References: