Eponychial Stent Study

NCT04409093 | Completed DMC

• 1 other identifier: 20-00355
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

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.

Conditions

Eponychial Stent; Nail Bed Injury

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Procedure time

  0-1 hour

Study Arms (2)

Nail bed repair with eponychial sent

EXPERIMENTAL

Procedure: Nail bed repair with eponychial sent

Nail bed repair without eponychial stent

ACTIVE COMPARATOR

Procedure: Nail bed repair without eponychial stent

Interventions

Nail bed repair with eponychial sent PROCEDURE

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.

Nail bed repair with eponychial sent

Nail bed repair without eponychial stent PROCEDURE

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.

Nail bed repair without eponychial stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Nail plate/bed injury secondary to bite wound

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (3)

NYU Langone Orthopedic Hospital

New York, New York, 10016, United States

Location

Tisch Hospital, NYU Langone Health

New York, New York, 10016, United States

Location

Jamaica Hospital Medical Center

Richmond Hill, New York, 11418, United States

Location

Study Officials

• Nader Paksima, DO MPH

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: June 1, 2020
• Study Start: June 1, 2020
• Primary Completion: August 24, 2023
• Study Completion: August 24, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• Access Criteria: Requests should be directed to ali.azad@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (3)