Management of Nailbed Injuries
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Study Team
- Phone Number: 650-723-5643
- Email: aluan@stanford.edu
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
|
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
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants who experience complications over time
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
Quick Disabilities of Arm, Shoulder, & Hand (QuickDASH) score, ranges from 0 (no disability) to 100 (most severe disability)
|
6 months
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Anna Luan, MD, Stanford University
- Principal Investigator: Jeffrey Yao, MD, Stanford University
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 59042
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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