Eponychial Stent Study

Not Applicable

Completed

• Conditions: Eponychial Stent; Nail Bed Injury
• Interventions: Procedure: Nail bed repair without eponychial stent; Procedure: Nail bed repair with eponychial sent

• Registration Number: NCT04409093
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-29
• Study Start: 2020-06-01
• Study First Posted: 2020-06-01
• Primary Completion: 2023-08-24
• Study Completion: 2023-08-24
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nail bed repair without eponychial stent	Nail bed repair without eponychial stent	-
Nail bed repair with eponychial sent	Nail bed repair with eponychial sent	-

Primary Outcome Measures

Name	Time	Method
Patient reported score on functional outcome scale (10-point analog scale)	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)	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)	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	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 Outcome Measures

Name	Time	Method
Procedure time	0-1 hour	To determine the added time taken to perform the eponychial stent following nail bed repair

Trial Locations

Locations (3)

NYU Langone Orthopedic Hospital; 🇺🇸 New York, New York, United States

Jamaica Hospital Medical Center; 🇺🇸 Richmond Hill, New York, United States

Tisch Hospital, NYU Langone Health; 🇺🇸 New York, New York, United States