Eponychial StentNCT04409093
Eponychial Stent Study
A study testing Nail bed repair with eponychial sent and Nail bed repair without eponychial stent in people with Eponychial Stent and Nail Bed Injury, run by NYU Langone Health at 3 sites in United States.
Trial summary
The study design is a prospective, randomized, controlled trial evaluating the cosmetic and functional outcomes of nail bed repairs with and without eponychial stents. Patients presenting to a single institution with a finger tip injury requiring a nail bed repair will be initially evaluated in the emergency… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eponychial Stent, Nail Bed Injury
- What is being tested?
- Nail bed repair with eponychial sent and Nail bed repair without eponychial stent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2020to 24 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, age > 18 years.
- Patients with either nail plate avulsion and/or fracture with associated nail bed injury or subungal hematoma > 50% with intact nail plate.
- Presentation within 8 hours of injury.
- Being treated at NYU Langone Health or Jamaica Hospital Medical Center.
- Willingness to participate in the study
Who cannot join
- 1. Nail plate/bed injury secondary to bite wound
Trial locations and contacts
3 sites in 1 country.
United States3 sites
NYU Langone Orthopedic Hospital
New York, New York, 10016
Tisch Hospital, NYU Langone Health
New York, New York, 10016
Jamaica Hospital Medical Center
Richmond Hill, New York, 11418
About this study
Official title: A Prospective, Randomized, Controlled Trial Evaluating the Utility of Eponychial Stents for Nail Re-growth in Nail Bed Injuries
The study design is a prospective, randomized, controlled trial evaluating the cosmetic and functional outcomes of nail bed repairs with and without eponychial stents. Patients presenting to a single institution with a finger tip injury requiring a nail bed repair will be initially evaluated in the emergency department. The purpose of the study will be explained to the patient, and informed consent for participation will be obtained. Patients will be randomly assigned to either the eponychial stent or no eponychial stent group based on the last digit of their assigned medical record number. Even-numbered patients will be randomized to the stent group and odd-numbered patients will be randomized to the no stent group. Demographic data will be obtained and recorded (age, gender, hand dominance, mechanism of injury, and past medical history). All patients will undergo a thorough clinical exam under digital nerve block followed by removal of the nail plate and thorough irrigation and debridement of devitalized tissue. The nail bed repair will be performed with 6-0 chromic suture material. After the nail bed repair, a stent (native nail, suture container foil, or nonadherent gauze) will or will not secured under the eponychial fold with suture depending on randomization. Laceration characteristic and time required to perform the procedure will be recorded. A nonadherent sterile dressing will be applied to the digit, and each patient will be discharged with a 5-day course of cephalexin for prophylaxis against infection. Follow-up evaluation will occur at 1 week, 1 month, 3 months, and 6 months. A each follow-up visit, patient-perceived functional outcome, cosmetic outcome, and level of pain will be assessed using a 10-point analog scale. Cosmetic results will also be evaluated by the examining physician using a validated physician-based outcome tool.
- Conditions
- Eponychial Stent, Nail Bed Injury
- Being tested
- Nail bed repair with eponychial sent, Nail bed repair without eponychial stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nail bed repair with eponychial sentProcedure or surgery
The nail bed repair will be performed with 6-0 chromic suture material. After the nail bed repair, an eponychial stent will be secured under the eponychial fold with suture. The stent can be the native nail plate, suture container foil, or nonadherent gauze (i.e. Xeroform). If the injury avulsed the nail plate and the patient presents without it, either the foil from the suture wrapper/container or a piece of nonadherent gauze (i.e. Xeroform) will be used as a stent. A nonadherent sterile dressing will be applied to the digit, and each patient will be discharged with a 5-day course of cephalexin for prophylaxis against infection.
Nail bed repair without eponychial stentProcedure or surgery
The nail bed repair will be performed with 6-0 chromic suture material. After the nail bed repair, an eponychial stent will not be secured under the eponychial fold. A nonadherent sterile dressing will be applied to the digit, and each patient will be discharged with a 5-day course of cephalexin for prophylaxis against infection.
| Study group | Role | What they receive |
|---|---|---|
| Nail bed repair with eponychial sent | Experimental | Not described Receives: Procedure: Nail bed repair with eponychial sent |
| Nail bed repair without eponychial stent | Active comparator | Not described Receives: Procedure: Nail bed repair without eponychial stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported score on functional outcome scale (10-point analog scale)
Mean score from all time points
0 = complete loss of affected digit function during activities of daily living and recreational activities 10 = no functional limitation
Measured: after procedure: 1 week, 1 month, 3 months, and 6 months
Patient reported score on cosmetic outcome scale (10-point analog scale)
Mean score from all time points
0 = cosmetically unacceptable 10 = no perceived difference between treated finger and the same finger on the contralateral hand
Measured: after procedure: 1 week, 1 month, 3 months, and 6 months
Patient reported pain level on Visual Analog Scale (VAS)
Mean score from all time points
0 = no pain 10 = persistent finger pain during rest and activity
Measured: after procedure: 1 week, 1 month, 3 months, and 6 months
Physician reported cosmetic outcome
Mean score from all time points
Zook et al. Excellent = identical in appearance to the same finger on the contralateral hand Very good = 1 variation from identical, such as incomplete adherence, nail ridging, split nails, or eponychial deformity.
Good = 2 minor variations from identical. Poor = more than 3 variations or 1 major variation from the same finger on the contralateral hand.
Measured: after procedure: 1 week, 1 month, 3 months, and 6 months
Secondary outcomes (1)
Procedure time
To determine the added time taken to perform the eponychial stent following nail bed repair
Measured: 0-1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start1 Jun 2020
- Primary completion24 Aug 2023
- Study completion24 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eponychial StentStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nader Paksima, DO MPH, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409093
- Sponsor's protocol ID
- 20-00355
- Status last verified
- Nov 2023
- First submitted
- 21 May 2020
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: \[contact information for PI or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Trial Evaluating the Utility of Eponychial Stents for Nail Re-growth in Nail Bed Injuries
- ClinicalTrials.gov ID
- NCT04409093
- Acronym / sponsor ID
- 20-00355
- Conditions
- Eponychial Stent, Nail Bed Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study design is a prospective, randomized, controlled trial evaluating the cosmetic and functional outcomes of nail bed repairs with and without eponychial stents. Patients presenting to a single institution with a finger tip injury requiring a nail bed repair will be initially evaluated in the emergency department. The purpose of the study will be explained to the patient, and informed consent for participation will be obtained. Patients will be randomly assigned to either the eponychial stent or no eponychial stent group based on the last digit of their assigned medical record number. Even-numbered patients will be randomized to the stent group and odd-numbered patients will be randomized to the no stent group. Demographic data will be obtained and recorded (age, gender, hand dominance, mechanism of injury, and past medical history). All patients will undergo a thorough clinical exam under digital nerve block followed by removal of the nail plate and thorough irrigation and debridement of devitalized tissue. The nail bed repair will be performed with 6-0 chromic suture material. After the nail bed repair, a stent (native nail, suture container foil, or nonadherent gauze) will or will not secured under the eponychial fold with suture depending on randomization. Laceration characteristic and time required to perform the procedure will be recorded. A nonadherent sterile dressing will be applied to the digit, and each patient will be discharged with a 5-day course of cephalexin for prophylaxis against infection. Follow-up evaluation will occur at 1 week, 1 month, 3 months, and 6 months. A each follow-up visit, patient-perceived functional outcome, cosmetic outcome, and level of pain will be assessed using a 10-point analog scale. Cosmetic results will also be evaluated by the examining physician using a validated physician-based outcome tool.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nail bed repair with eponychial sent | Experimental | Procedure: Nail bed repair with eponychial sent |
| Nail bed repair without eponychial stent | Active comparator | Procedure: Nail bed repair without eponychial stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women, age > 18 years.
- Patients with either nail plate avulsion and/or fracture with associated nail bed injury or subungal hematoma > 50% with intact nail plate.
- Presentation within 8 hours of injury.
- Being treated at NYU Langone Health or Jamaica Hospital Medical Center.
- Willingness to participate in the study
Key exclusion criteria (1 listed)
- 1. Nail plate/bed injury secondary to bite wound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nail bed repair with eponychial sentThe nail bed repair will be performed with 6-0 chromic suture material. After the nail bed repair, an eponychial stent will be secured under the eponychial fold with suture. The stent can be the native nail plate, suture container foil, or nonadherent gauze (i.e. Xeroform). If the injury avulsed the nail plate and the patient presents without it, either the foil from the suture wrapper/container or a piece of nonadherent gauze (i.e. Xeroform) will be used as a stent. A nonadherent sterile dressing will be applied to the digit, and each patient will be discharged with a 5-day course of cephalexin for prophylaxis against infection. | Procedure or surgery | Nail bed repair with eponychial sent |
| Nail bed repair without eponychial stentThe nail bed repair will be performed with 6-0 chromic suture material. After the nail bed repair, an eponychial stent will not be secured under the eponychial fold. A nonadherent sterile dressing will be applied to the digit, and each patient will be discharged with a 5-day course of cephalexin for prophylaxis against infection. | Procedure or surgery | Nail bed repair without eponychial stent |
Primary outcome
Patient reported score on functional outcome scale (10-point analog scale)
Time frame: after procedure: 1 week, 1 month, 3 months, and 6 months
Mean score from all time points 0 = complete loss of affected digit function during activities of daily living and recreational activities 10 = no functional limitation
Patient reported score on cosmetic outcome scale (10-point analog scale)
Time frame: after procedure: 1 week, 1 month, 3 months, and 6 months
Mean score from all time points 0 = cosmetically unacceptable 10 = no perceived difference between treated finger and the same finger on the contralateral hand
Patient reported pain level on Visual Analog Scale (VAS)
Time frame: after procedure: 1 week, 1 month, 3 months, and 6 months
Mean score from all time points 0 = no pain 10 = persistent finger pain during rest and activity
Physician reported cosmetic outcome
Time frame: after procedure: 1 week, 1 month, 3 months, and 6 months
Mean score from all time points Zook et al. Excellent = identical in appearance to the same finger on the contralateral hand Very good = 1 variation from identical, such as incomplete adherence, nail ridging, split nails, or eponychial deformity. Good = 2 minor variations from identical. Poor = more than 3 variations or 1 major variation from the same finger on the contralateral hand.
1 secondary outcome
Procedure time
Time frame: 0-1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [contact information for PI or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nader Paksima, DO MPH principal investigator
NYU Langone Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nail bed repair with eponychial sent and Nail bed repair without eponychial stent in people with Eponychial Stent and Nail Bed Injury, run by NYU Langone Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported score on functional outcome scale (10-point analog scale) (time frame: after procedure: 1 week, 1 month, 3 months, and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023; AzTrials last refreshed its copy on 2 Nov 2026.