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Management of Nailbed Injuries

Primary Purpose

Nail Bed Injury

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nail plate removal, nail bed repair
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nail Bed Injury

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Nail plate removal, nail bed repair

    Observation

    Arm Description

    Participants will undergo nail plate removal and nail bed repair, and follow up at clinic visits at 1 week, 3 months, and 6 months

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

    Outcomes

    Primary Outcome Measures

    Number of participants who experience complications over time
    Any complication, including but not limited to infection or wound healing complications
    Change in pain score over time as measured on a pain scale
    Scored from 0-10 (higher scores indicate worse pain)
    Change in cosmetic appearance over time as measured by the Oxford Finger Nail Appearance Score
    Oxford Finger Nail Appearance Score
    Change in upper extremity function over time as measured by the QuickDash score
    QuickDASH score

    Secondary Outcome Measures

    Full Information

    First Posted
    November 26, 2020
    Last Updated
    November 26, 2020
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04652635
    Brief Title
    Management of Nailbed Injuries
    Official Title
    Management of Nailbed Injuries
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2050 (Anticipated)
    Study Completion Date
    December 31, 2050 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nail Bed Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    6 month appearance will be assessed by a blinded individual
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Nail plate removal, nail bed repair
    Arm Type
    Active Comparator
    Arm Description
    Participants will undergo nail plate removal and nail bed repair, and follow up at clinic visits at 1 week, 3 months, and 6 months
    Arm Title
    Observation
    Arm Type
    No Intervention
    Arm Description
    Participants will follow up at clinic visits at 1 week, 3 months, and 6 months
    Intervention Type
    Procedure
    Intervention Name(s)
    Nail plate removal, nail bed repair
    Intervention Description
    Injection of local anesthetic, removal of nail plate, inspection of nail bed, repair of nail bed with suture and/or adhesive
    Primary Outcome Measure Information:
    Title
    Number of participants who experience complications over time
    Description
    Any complication, including but not limited to infection or wound healing complications
    Time Frame
    6 months
    Title
    Change in pain score over time as measured on a pain scale
    Description
    Scored from 0-10 (higher scores indicate worse pain)
    Time Frame
    6 months
    Title
    Change in cosmetic appearance over time as measured by the Oxford Finger Nail Appearance Score
    Description
    Oxford Finger Nail Appearance Score
    Time Frame
    6 months
    Title
    Change in upper extremity function over time as measured by the QuickDash score
    Description
    QuickDASH score
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Study Team
    Phone
    650-723-5643
    Email
    aluan@stanford.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anna Luan, MD
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jeffrey Yao, MD
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Management of Nailbed Injuries

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