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Purpose

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?"

Conditions

Eligibility

Eligible Ages
Over 2 Years
Eligible Sex
All
Accepts 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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
No nail bed repair (Irrigation and Dressing) 		Patients in this arm will receive the following treatment protocol: 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, Adaptic or 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 6. Discharge on Keflex x7d with referral for followup in hand clinic in 1-2 weeks
  • Other: Nail 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
Experimental
Nail bed repair 		Patients in this arm will receive the following treatment protocol: 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. Fashion substitute nail from foil suture packet, stent eponychium, and secure with 2 absorbable sutures 7. Dress finger with bacitracin, Adaptic or 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 10. Discharge on Keflex x7d with referral for followup in hand clinic in 1-2 weeks
  • Other: Nail 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

Recruiting Locations

Stanford University
Palo Alto, California 94305

More Details

Status
Recruiting
Sponsor
Stanford University

Study Contact

Sara Kemper
650 725 7897
sara.kemper@stanford.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.