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
About this trial
This is an interventional treatment trial for Nail Bed Injury
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
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
NCT ID
NCT04652635
First Posted
November 26, 2020
Last Updated
November 26, 2020
Sponsor
Stanford University
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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