- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04652635
Management of Nailbed Injuries
November 26, 2020 updated by: Anna Luan, Stanford University
The purpose of the study is to determine whether nail plate removal in suspected nailbed injury improves patient outcomes.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Study Team
- Phone Number: 650-723-5643
- Email: aluan@stanford.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
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
|
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
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
|
6 months
|
Change in upper extremity function over time as measured by the QuickDash score
Time Frame: 6 months
|
QuickDASH score
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anna Luan, MD, Stanford University
- Principal Investigator: Jeffrey Yao, MD, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
December 1, 2020
Primary Completion (ANTICIPATED)
December 31, 2050
Study Completion (ANTICIPATED)
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)
December 3, 2020
Last Update Submitted That Met QC Criteria
November 26, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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