Nailbed Repair for Patients With Nailbed Injuries

NCT07388823 | Not Yet Recruiting

• 1 other identifier: 82680
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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?"

Conditions

Nail Laceration; Nail Plate Disruption; Nail Bed Injury

Outcome Measures

Primary Outcomes (1)

• Oxford Nail Score

  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."

  From time of treatment, outcomes will be measured at 1-2 weeks, 6 months, 1 year, and 2 years

Secondary Outcomes (4)

• Subjective Cosmesis

  1-2 weeks, 6 months, 1 year, 2 years

• NRS Pain score

  1-2 weeks, 6 months, 1 year, 2 years

• Nail regrowth

  1-2 weeks, 6 weeks, 1 year, 2 years

• Evidence of infection

  1-2 weeks, 6 months, 1 year, 2 years

Study Arms (2)

Irrigation and Dressing

ACTIVE COMPARATOR

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, 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

Other: Nail bed dressing

Nail bed repair

EXPERIMENTAL

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. 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

Other: Nail Bed Repair

Interventions

Nail Bed Repair OTHER

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

Nail bed repair

Nail bed dressing OTHER

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

Irrigation and Dressing

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead

Related Publications (3)

• Zook EG, Guy RJ, Russell RC. A study of nail bed injuries: causes, treatment, and prognosis. J Hand Surg Am. 1984 Mar;9(2):247-52. doi: 10.1016/s0363-5023(84)80153-7.

  PMID: 6715836 BACKGROUND

• Ashbell TS, Kleinert HE, Putcha SM, Kutz JE. The deformed finger nail, a frequent result of failure to repair nail bed injuries. J Trauma. 1967 Mar;7(2):177-90. doi: 10.1097/00005373-196703000-00001. No abstract available.

  PMID: 5335262 BACKGROUND

• Rao V, Akiki RK, Crozier JW, Bhatt RA, Schmidt ST, Kalliainen LK. Rethinking the Need for Nail Plate Removal: A Comparison of the Risks Between Standard Nail Bed Repair and Nonoperative Management. Ann Plast Surg. 2022 May 1;88(3 Suppl 3):S209-S213. doi: 10.1097/SAP.0000000000003197.

  PMID: 35513322 BACKGROUND

Central Study Contacts

Sara Kemper

CONTACT

650 725 7897; sara.kemper@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 5, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 31, 2030
• Study Completion (Estimated): October 31, 2030
• Last Updated: April 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share