Eponychial Stent, Nail Bed Injury
Conditions
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.
Interventions
PROCEDURENail 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.
PROCEDURENail 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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Procedure time | 0-1 hour | To determine the added time taken to perform the eponychial stent following nail bed repair |
Countries
United States
Outcome results
None listed