CLINICAL TRIAL

Nail bed repair with eponychial sent for Wounds

Recruiting · 18+ · All Sexes · New York, NY

This study is evaluating whether a plastic tube placed in the nail bed may help improve the appearance of a nail bed after a nail injury.

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About the trial for Wounds

Eligible Conditions
Eponychial Stent · Wounds and Injuries · Nail Bed Injury

Treatment Groups

This trial involves 2 different treatments. Nail Bed Repair With Eponychial Sent is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Nail bed repair with eponychial sent
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Nail bed repair without eponychial stent
PROCEDURE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: after procedure: 1 week, 1 month, 3 months, and 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: after procedure: 1 week, 1 month, 3 months, and 6 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Nail bed repair with eponychial sent will improve 4 primary outcomes and 1 secondary outcome in patients with Wounds. Measurement will happen over the course of 0-1 hour.

Procedure time
0-1 HOUR
To determine the added time taken to perform the eponychial stent following nail bed repair
Patient reported pain level on Visual Analog Scale (VAS)
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
Patient reported score on functional outcome scale (10-point analog scale)
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)
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
Physician reported cosmetic outcome
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.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is wounds?

This article discusses a broad spectrum of wounds, their underlying causes (i.e., predisposing factors, contributing factors, and risk factors), and the appropriate treatment and management of many different wounds.\n

Anonymous Patient Answer

What are common treatments for wounds?

Tissue grafting is commonly used despite a lack of good evidence to support its routine use. No randomised controlled trials support the use of either a dressing or topical antimicrobial ointment or antibacterial ointment as a standard way to dress or treat wounds; thus, the practice remains highly controversial. For wound healing, autologous and alloic wound healing techniques are preferred, but the quality and quantity of evidence to support autologous wound healing is very low, with only one study showing a significant difference in healing time in the use of autologous versus allogenic skin compared with a standard medical treatment.

Anonymous Patient Answer

How many people get wounds a year in the United States?

Approximately 6.8 million US adults develop wounds each year, making up 4% of adults. Over the past 20 years, the incidence of wounds has increased, most likely due to the effects of ageing on the immune system.

Anonymous Patient Answer

Can wounds be cured?

Contrary to popular belief, wounds that do not require closure will close on their own spontaneously. Treatment with a simple bandage and plaster of Paris casts does, unfortunately, have no effect on wound healing.

Anonymous Patient Answer

What are the signs of wounds?

Symptoms of chronic wounds such as impaired sensation and impaired sensation of temperature, pain, and itching may not be noticed by patients unless they are asked specifically about their wounds. Chronic wounds may also fail to elicit symptoms that are indicative of infection. Clinicians should consider screening patients at the time of presenting wound for signs of infection before starting treatments.

Anonymous Patient Answer

What causes wounds?

Wounds may be caused by exposure to bacteria, or chemical toxins. In babies, they may be caused by low blood sugar levels. Wounds may be the result of an attack on a bug, a bite by a mosquito, or a bite from a spider. When the wound is from a spider bite, it almost always leads to a tick bite. The bite of a spider or tick may be blocked by antivenom.

Anonymous Patient Answer

What is the average age someone gets wounds?

The average age for sustaining non-operative wounds was 30.9 years (95% confidence interval, 29.4 to 31.8), increasing over time. Wounds to the face and hands were more common at younger ages. Wounds to the mouth, foot, and ankle were more common in adults than young adults (65.9 years versus 20.8 years, respectively).

Anonymous Patient Answer

What does nail bed repair with eponychial sent usually treat?

Eponychial sent has been used to repair major burn wound in the past and proven to be a good solution when necrotic tissues do not exist. Due to limited evidences for eponychial sent, this can not be said whether or not eponychial sent can be used especially to repair nail bed wound. This article presents a case report on eponychial sent, and provides an overview of the current evidence of eponychial sent with wound healing considerations.

Anonymous Patient Answer

Who should consider clinical trials for wounds?

Patients should consider clinical trials that offer benefits that may help them manage their condition. It is important to note that the benefit to the clinical trial sponsor does not justify the risk of experiencing serious adverse events or receiving an unnecessary treatment. Moreover, when searching clinical trials, it is important to be aware of the possibility that some clinical trials may use non-compliant patients to obtain statistically significant results. Additionally, we suggest that clinicians do not hesitate to recommend clinical trials when the potential benefits of treatment are clear.

Anonymous Patient Answer

Does wounds run in families?

These data show a significant degree of familial transmission of venous leg ulcer among families of individuals with venous leg ulcer. This emphasizes the importance of the shared family environment in the etiology of venous leg ulcers. It should be of concern to all clinicians working in the field of venous leg ulcer.

Anonymous Patient Answer

What is the latest research for wounds?

There appears to be a limited number of publications for the treatment of chronic wounds such as pressure ulcers. However, there is an abundance of evidence for the effectiveness of dressing changes and wound cleansing using topical debridement. Additional well-designed randomized control trials are needed to evaluate their benefits and side effects. Also, there is an urgent need for new biologic therapies for chronic wounds to be developed.

Anonymous Patient Answer

How does nail bed repair with eponychial sent work?

Results from a recent paper, eponychial sutures have a higher likelihood of failure compared with end-to-end sutures. Nail bed repair is an ambulatory procedure and is an excellent alternative for wounds that fail to heal.

Anonymous Patient Answer
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