Nail Bed Injury, Nail Laceration, Nail Plate Disruption
Conditions
Brief summary
This study compares the outcomes of fixing nail bed injuries with nail bed repair versus irrigation and dressing alone. The main question this study aims to answer is "Does nail bed repair after nail bed injury lead to better outcomes?"
Detailed description
This study compares two treatment methods for patients with nail bed injuries. The first method is irrigation and dressing. The second method is nail bed repair. Patients will be randomized into one of the two groups and outcomes will be documented in both groups.
Interventions
OTHERNail Bed Repair
1. Block involved digit with 3cc 1% lidocaine injected subcutaneously over volar and dorsal metacarpophalangeal joint 2. Apply tourniquet to base of finger if desired 3. Remove nail using freer/hemostats 4. Irrigate wound with at least 500cc normal saline 5. Repair nail bed laceration with 5-0 chromic or monocryl suture 6. Stent eponychium with native nail or fashion substitute from foil suture packet and secure with 2 sutures 7. Dress finger with bacitracin, xeroform, and 2" kling wrap 8. Splint finger as needed with alumifoam splint (apply splint to volar side of finger so as to avoid pressure to nail bed) 9. Repair any other lacerations as needed
OTHERNail bed dressing
1. If there is a subungual hematoma \>50% of the nail, trephinate the nail plate using an 18G needle 2. Irrigate wound with at least 500cc normal saline 3. Dress finger with bacitracin, xeroform, and 2" kling wrap 4. Splint finger as needed with alumifoam splint (apply splint to volar side of finger so as to avoid pressure to nail bed) 5. Repair any other lacerations as needed
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients 2+ years of age * presenting with disruption of nail plate or laceration adjacent to nail which appears that it may extend into the nail matrix OR subungual hematoma \>50% of nail * presenting within 3 days of acute injury
Exclusion criteria
* missing (e.g. avulsed) nail bed or segment of nail bed, * prior injury to affected nail * need for surgical treatment of injury (e.g. underlying operative fracture)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Nail Score | From time of treatment, outcomes will be measured at 1-2 weeks, 6 months, 1 year, and 2 years | The Oxford Nail Score assess five cosmetic components marked as binary outcomes composed of nail shape, nail adherence, eponychial appearance, nail surface appearance and presence of a split. The final score is 0-5, where 0 is "least optimal appearance" and 5 is "most optimal appearance." |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Cosmesis | 1-2 weeks, 6 months, 1 year, 2 years | Patients will self-score their cosmesis on a 5-point Likert scale, from "excellent" to "very poor" |
| NRS Pain score | 1-2 weeks, 6 months, 1 year, 2 years | Patients will rate their nailbed on a 0-10 scale, where 0 is no pain and 10 is the worst pain imaginable. |
| Nail regrowth | 1-2 weeks, 6 weeks, 1 year, 2 years | Nail regrowth will be documented on a binary scale (yes or no) by an evaulator via photo. |
| Evidence of infection | 1-2 weeks, 6 months, 1 year, 2 years | Evidence of infection will be evaluated on a binary scale (yes or no) by an evaluator via photo. |
Countries
United States
Contacts
CONTACTSara Kemper
Outcome results
None listed