Eponychial Stent Study

A Prospective, Randomized, Controlled Trial Evaluating the Utility of Eponychial Stents for Nail Re-growth in Nail Bed Injuries

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.

Study Overview

• Status: Completed
• Conditions: Nail Bed Injury; Eponychial Stent
• Intervention / Treatment: Procedure: Nail bed repair with eponychial sent; Procedure: Nail bed repair without eponychial stent

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ali Azad, MD; Phone Number: 212-263-2192; Email: ali.azad@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Orthopedic Hospital
    • New York, New York, United States, 10016
      • Tisch Hospital, NYU Langone Health
    • Richmond Hill, New York, United States, 11418
      • Jamaica Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nail bed repair with eponychial sent	Procedure: Nail bed repair with eponychial sent; The nail bed repair will be performed with 6-0 chromic suture material. After the nail bed repair, an eponychial stent will be secured under the eponychial fold with suture. The stent can be the native nail plate, suture container foil, or nonadherent gauze (i.e. Xeroform). If the injury avulsed the nail plate and the patient presents without it, either the foil from the suture wrapper/container or a piece of nonadherent gauze (i.e. Xeroform) will be used as a stent. 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.
Active Comparator: Nail bed repair without eponychial stent	Procedure: Nail bed repair without eponychial stent; The nail bed repair will be performed with 6-0 chromic suture material. After the nail bed repair, an eponychial stent will not be secured under the eponychial fold. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported score on functional outcome scale (10-point analog scale)	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	after procedure: 1 week, 1 month, 3 months, and 6 months
Patient reported score on cosmetic outcome scale (10-point analog scale)	Mean score from all time points 0 = cosmetically unacceptable 10 = no perceived difference between treated finger and the same finger on the contralateral hand	after procedure: 1 week, 1 month, 3 months, and 6 months
Patient reported pain level on Visual Analog Scale (VAS)	Mean score from all time points 0 = no pain 10 = persistent finger pain during rest and activity	after procedure: 1 week, 1 month, 3 months, and 6 months
Physician reported cosmetic outcome	Mean score from all time points Zook et al. Excellent = identical in appearance to the same finger on the contralateral hand Very good = 1 variation from identical, such as incomplete adherence, nail ridging, split nails, or eponychial deformity. Good = 2 minor variations from identical. Poor = more than 3 variations or 1 major variation from the same finger on the contralateral hand.	after procedure: 1 week, 1 month, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure time	To determine the added time taken to perform the eponychial stent following nail bed repair	0-1 hour

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Nader Paksima, DO MPH, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): August 24, 2023
• Study Completion (Actual): August 24, 2023

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20-00355

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [contact information for PI or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: Requests should be directed to ali.azad@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No