Nailbed Repair for Patients With Nailbed Injuries

Nail Bed Repair RCT

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?"

Study Overview

• Status: Not yet recruiting
• Conditions: Nail Bed Injury; Nail Laceration; Nail Plate Disruption
• Intervention / Treatment: Other: Nail bed dressing; Other: Nail Bed Repair

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Kemper; Phone Number: 650 725 7897; Email: sara.kemper@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Irrigation and Dressing; Patients in this arm will receive the following treatment protocol: If there is a subungual hematoma >50% of the nail, trephinate the nail plate using an 18G needle; Irrigate wound with at least 500cc normal saline; Dress finger with bacitracin, xeroform, and 2" kling wrap; Splint finger as needed with alumifoam splint (apply splint to volar side of finger so as to avoid pressure to nail bed); Repair any other lacerations as needed	Other: Nail bed dressing; If there is a subungual hematoma >50% of the nail, trephinate the nail plate using an 18G needle; Irrigate wound with at least 500cc normal saline; Dress finger with bacitracin, xeroform, and 2" kling wrap; Splint finger as needed with alumifoam splint (apply splint to volar side of finger so as to avoid pressure to nail bed); Repair any other lacerations as needed
Experimental: Nail bed repair; Patients in this arm will receive the following treatment protocol: Block involved digit with 3cc 1% lidocaine injected subcutaneously over volar and dorsal metacarpophalangeal joint; Apply tourniquet to base of finger if desired; Remove nail using freer/hemostats; Irrigate wound with at least 500cc normal saline; Repair nail bed laceration with 5-0 chromic or monocryl suture; Stent eponychium with native nail or fashion substitute from foil suture packet and secure with 2 sutures; Dress finger with bacitracin, xeroform, and 2" kling wrap; Splint finger as needed with alumifoam splint (apply splint to volar side of finger so as to avoid pressure to nail bed); Repair any other lacerations as needed	Other: Nail Bed Repair; Block involved digit with 3cc 1% lidocaine injected subcutaneously over volar and dorsal metacarpophalangeal joint; Apply tourniquet to base of finger if desired; Remove nail using freer/hemostats; Irrigate wound with at least 500cc normal saline; Repair nail bed laceration with 5-0 chromic or monocryl suture; Stent eponychium with native nail or fashion substitute from foil suture packet and secure with 2 sutures; Dress finger with bacitracin, xeroform, and 2" kling wrap; Splint finger as needed with alumifoam splint (apply splint to volar side of finger so as to avoid pressure to nail bed); Repair any other lacerations as needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nail regrowth	Nail regrowth will be documented on a binary scale (yes or no) by an evaulator via photo.	1-2 weeks, 6 weeks, 1 year, 2 years
Subjective Cosmesis	Patients will self-score their cosmesis on a likert scale, with lower scores indicated better cosmesis. This will be scored from 0 to 8.	1-2 weeks, 6 months, 1 year, 2 years
NRS Pain score	Patients will rate their nailbed on a 0-10 scale, where 0 is no pain and 10 is the worst pain imaginable.	1-2 weeks, 6 months, 1 year, 2 years
Evidence of infection	Evidence of infection will be evaluated on a binary scale (yes or no) by an evaluator via photo.	1-2 weeks, 6 months, 1 year, 2 years

Collaborators and Investigators

• Sponsor: Stanford University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 31, 2030
• Study Completion (Estimated): October 31, 2030

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 82680

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not have plans to share this data set.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No