Eponychial Stent Study

Nail Bed Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04409093
• Other study ID #: 20-00355
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: August 24, 2023

Study information

• Verified date: November 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 24, 2023
• Est. primary completion date: August 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eponychial Stent
• Nail Bed Injury

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Orthopedic Hospital	New York	New York
United States	Tisch Hospital, NYU Langone Health	New York	New York
United States	Jamaica Hospital Medical Center	Richmond Hill	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Procedure time	To determine the added time taken to perform the eponychial stent following nail bed repair	0-1 hour