Management of Nailbed Injuries

The purpose of the study is to determine whether nail plate removal in suspected nailbed injury improves patient outcomes.

Study Overview

• Status: Withdrawn
• Conditions: Nail Bed Injury
• Intervention / Treatment: Procedure: Nail plate removal, nail bed repair

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• any individual greater than or equal to 2 years of age presenting with a suspected nailbed injury (laceration adjacent to or through nail plate and/or subungual hematoma) with the nail plate present

Exclusion Criteria:

• nail plate absent over the nailbed injury

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nail plate removal, nail bed repair; Participants will undergo nail plate removal and nail bed repair, and follow up at clinic visits at 1 week, 3 months, and 6 months	Procedure: Nail plate removal, nail bed repair; Injection of local anesthetic, removal of nail plate, inspection of nail bed, repair of nail bed with suture and/or adhesive
No Intervention: Observation; Participants will follow up at clinic visits at 1 week, 3 months, and 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who experience complications over time	Any complication, including but not limited to infection or wound healing complications	6 months
Change in pain score over time as measured on a pain scale	Scored from 0-10 (higher scores indicate worse pain)	6 months
Change in cosmetic appearance over time as measured by the Oxford Finger Nail Appearance Score	Oxford Finger Nail Appearance Score (OFNAS), ranges from 0 to 5 (5 is the best appearance)	6 months
Change in upper extremity function over time as measured by the QuickDash score	Quick Disabilities of Arm, Shoulder, & Hand (QuickDASH) score, ranges from 0 (no disability) to 100 (most severe disability)	6 months

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Anna Luan, MD, Stanford University; Principal Investigator: Jeffrey Yao, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 31, 2050
• Study Completion (Estimated): December 31, 2050

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: November 26, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 59042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No