NCT04652635

Brief Summary

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

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
293mo left

Started Dec 2026

Longer than P75 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
6 years until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
24.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2050

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2050

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

24.1 years

First QC Date

November 26, 2020

Last Update Submit

March 2, 2026

Conditions

Nail Bed Injury

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Nail plate removal, nail bed repair

ACTIVE COMPARATOR

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

Observation

NO INTERVENTION

Participants will follow up at clinic visits at 1 week, 3 months, and 6 months

Interventions

Nail plate removal, nail bed repairPROCEDURE

Injection of local anesthetic, removal of nail plate, inspection of nail bed, repair of nail bed with suture and/or adhesive

Nail plate removal, nail bed repair

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • nail plate absent over the nailbed injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Anna Luan, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Jeffrey Yao, MD

    Stanford University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
6 month appearance will be assessed by a blinded individual
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in Surgery

Study Record Dates

First Submitted

November 26, 2020

First Posted

December 3, 2020

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 31, 2050

Study Completion (Estimated)

December 31, 2050

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share