Skip to main content
Clinical Trials/NCT04409093
NCT04409093
Completed
N/A

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

NYU Langone Health3 sites in 1 country54 target enrollmentJune 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Eponychial Stent
Sponsor
NYU Langone Health
Enrollment
54
Locations
3
Primary Endpoint
Patient reported score on functional outcome scale (10-point analog scale)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
August 24, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Patient reported score on functional outcome scale (10-point analog scale)

Time Frame: after procedure: 1 week, 1 month, 3 months, and 6 months

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

Patient reported score on cosmetic outcome scale (10-point analog scale)

Time Frame: after procedure: 1 week, 1 month, 3 months, and 6 months

Mean score from all time points 0 = cosmetically unacceptable 10 = no perceived difference between treated finger and the same finger on the contralateral hand

Patient reported pain level on Visual Analog Scale (VAS)

Time Frame: after procedure: 1 week, 1 month, 3 months, and 6 months

Mean score from all time points 0 = no pain 10 = persistent finger pain during rest and activity

Physician reported cosmetic outcome

Time Frame: after procedure: 1 week, 1 month, 3 months, and 6 months

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.

Secondary Outcomes

  • Procedure time(0-1 hour)

Study Sites (3)

Loading locations...

Similar Trials