Nailbed Repair for Patients With Nailbed Injuries
Nail Bed Repair RCT
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Sara Kemper
- Phone Number: 650 725 7897
- Email: sara.kemper@stanford.edu
Study Locations
-
-
California
-
Palo Alto, California, United States, 94305
- Recruiting
- Stanford University
-
Principal Investigator:
- Anna Luan, MD
-
Principal Investigator:
- Rachel Roller, MD
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- patients 2+ years of age
- presenting with disruption of nail plate or laceration adjacent to nail which appears that it may extend into the nail matrix OR subungual hematoma >50% of nail
- presenting within 3 days of acute injury
Exclusion Criteria:
- missing (e.g. avulsed) nail bed or segment of nail bed,
- prior injury to affected nail
- need for surgical treatment of injury (e.g. underlying operative fracture)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: No nail bed repair (Irrigation and Dressing)
Patients in this arm will receive the following treatment protocol:
|
|
|
Experimental: Nail bed repair
Patients in this arm will receive the following treatment protocol:
|
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oxford Nail Score
Time Frame: From time of treatment, outcomes will be measured at 1-2 weeks, 6 months, 1 year, and 2 years
|
The Oxford Nail Score assess five cosmetic components marked as binary outcomes composed of nail shape, nail adherence, eponychial appearance, nail surface appearance and presence of a split.
The final score is 0-5, where 0 is "least optimal appearance" and 5 is "most optimal appearance."
|
From time of treatment, outcomes will be measured at 1-2 weeks, 6 months, 1 year, and 2 years
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nail regrowth
Time Frame: 1-2 weeks, 6 weeks, 1 year, 2 years
|
Nail regrowth will be documented on a binary scale (yes or no) by an evaulator via photo.
|
1-2 weeks, 6 weeks, 1 year, 2 years
|
|
NRS Pain score
Time Frame: 1-2 weeks, 6 months, 1 year, 2 years
|
Patients will rate their nailbed on a 0-10 scale, where 0 is no pain and 10 is the worst pain imaginable.
|
1-2 weeks, 6 months, 1 year, 2 years
|
|
Evidence of infection
Time Frame: 1-2 weeks, 6 months, 1 year, 2 years
|
Evidence of infection will be evaluated on a binary scale (yes or no) by an evaluator via photo.
|
1-2 weeks, 6 months, 1 year, 2 years
|
|
Subjective Cosmesis
Time Frame: 1-2 weeks, 6 months, 1 year, 2 years
|
Patients will self-score their cosmesis on a 5-point Likert scale, from "excellent" to "very poor"
|
1-2 weeks, 6 months, 1 year, 2 years
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
General Publications
- Zook EG, Guy RJ, Russell RC. A study of nail bed injuries: causes, treatment, and prognosis. J Hand Surg Am. 1984 Mar;9(2):247-52. doi: 10.1016/s0363-5023(84)80153-7.
- Ashbell TS, Kleinert HE, Putcha SM, Kutz JE. The deformed finger nail, a frequent result of failure to repair nail bed injuries. J Trauma. 1967 Mar;7(2):177-90. doi: 10.1097/00005373-196703000-00001. No abstract available.
- Rao V, Akiki RK, Crozier JW, Bhatt RA, Schmidt ST, Kalliainen LK. Rethinking the Need for Nail Plate Removal: A Comparison of the Risks Between Standard Nail Bed Repair and Nonoperative Management. Ann Plast Surg. 2022 May 1;88(3 Suppl 3):S209-S213. doi: 10.1097/SAP.0000000000003197.
Study record dates
Study Major Dates
Study Start (Actual)
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
Other Study ID Numbers
Other Study ID Numbers
- 82680
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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