Nail Bed InjuryOngl'HUSNCT03013608
Children's Nail Bed Injuries : Study of the Efficacy of the Simple Relocation of Nail Plate
A study testing Simple relocation of the nail plate in nailbed injuries in paediatric population in people with Nail Bed Injury, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Nail bed injuries in children, most frequently under 3 years-old, result in crush injuries. The frequency is around 34 percent of the children hand injuries (Claudet et al, 2007). The empirical reparation technique is the nail bed suture and the relocation of the nail plate. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Nail Bed Injury
- What is being tested?
- Simple relocation of the nail plate in nailbed injuries in paediatric population
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 22 May 2017to 19 Jun 2020
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age under 18 yo
- nail bed injuries and/or nail matrix
- nail plate > 30% of the surface comparing the opposite side
- one or more digits
- signature of the 2 parents
- social security
Who cannot join
- loss of more than 30% of the surface of the nail bed
- Multiples lesions: nerve injury, tendon, fracture or luxation without indication of osteosynthesis, loss of skin with indication of a flap
- osteosynthesis of the distal phalanx
- injuries by bite
- previous pathology of the nail
- contraindication of Lidocaine, bicarbonate de sodium, Kalinox, Biseptine, Vicryl rapide, Adaptic
Show all 10Show fewer
- no information possible
- pregnancy
- breastfeeding
- other inclusion in another study
Trial locations and contacts
1 site in 1 country.
About this study
Nail bed injuries in children, most frequently under 3 years-old, result in crush injuries. The frequency is around 34 percent of the children hand injuries (Claudet et al, 2007). The empirical reparation technique is the nail bed suture and the relocation of the nail plate. However, some authors think that suture the nail bed could increase the traumatism of the nail bed because of the needle, the crush by the clamps and by the stitches too tight (Langlois, Yam). An author has proposed, in a prospective, randomized clinical trial to treat the nail bed injuries with a glue: the 2-octylcyanoacrylate, without suture of the nail bed. Advantages of this technique, claimed by the author, was time saving, with an aesthetical result as same as the treatment with suture of the nail bed. A same study validated the technique in a paediatric population (Langlois et al., 2010). So, it seems that it is not necessary to suture the nail bed. But, in our practice, the investigators noted complications not mentioned in previous studies: hematomas causing pain, effusion and dislocation of the nail plate, with constrain the patient to consult in emergency. The 2-octylcyanoacrylate is difficult to use in nail bed injuries and is expensive. Our hypothesis is the simple relocation of the nail plate in nail bed injuries in paediatric population is enough to have good to excellent aesthetical results, with less complications and a lower cost, than the other techniques. The aim of this study is to assess the aesthetical results 3 months after simple relocation of the nail plate for nail bed injuries in children.
- Conditions
- Nail Bed Injury
- Being tested
- Simple relocation of the nail plate in nailbed injuries in paediatric population
- Keywords
- Nail bed injury, Nail bed injuries, Nail, Children, Fingertip injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple relocation of the nail plate in nailbed injuries in paediatric populationProcedure or surgery
Also called Reparation of the nail bed injuries, Repositioning the nail bed without sutures, Relocation of the nail
Repositioning the nail bed without sutures
| Study group | Role | What they receive |
|---|---|---|
| relocation of nail plate | Experimental | the simple relocation of the nail plate in nailbed injuries in paediatric population Receives: Procedure: Simple relocation of the nail plate in nailbed injuries in paediatric population |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nail aesthetical results
Evaluation with the Zook's scale at 6 months postoperative based on photographs of the injured finger compared with the finger on the opposite side. The evaluation will be done by five persons (surgeons, nurses, therapists….)
Measured: The evaluation is assessed at 6 months after the treatmen6
Secondary outcomes (4)
Complications rate at short term (before 15 days): haematoma, infection, dislocation of the nail plate,: hook nail
Measured: at 15 days
The pain with an analogic scale for children over 7 years-old,
Measured: at 6 months
Satisfaction rate at 6 months, compared with the contralateral finger, by the children (if possible) and by parents, on a scale to 0 (not satisfied) to 10 (very satisfied).
photographs, evaluation of the roughness by the surgeon, the nurse and parents, satisfaction of the aspect of the nail on a scale (0 to 10)
Measured: at 6 months
Complications rate: haematoma, infection, dislocation of the nail plate,at medium term (between 15 days and 3 months): hook nail
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start22 May 2017
- Primary completion19 Jun 2020
- Study completion19 Jun 2020
Why it stopped: recruitment difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nail Bed InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013608
- Sponsor's protocol ID
- 6529
- Acronym
- Ongl'HUS
- Status last verified
- Aug 2019
- First submitted
- 4 Jan 2017
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children's Nail Bed Injuries : Study of the Efficacy of the Simple Relocation of Nail Plate
- ClinicalTrials.gov ID
- NCT03013608
- Acronym / sponsor ID
- Ongl'HUS / 6529
- Conditions
- Nail Bed Injury
- Keywords
- Nail bed injury, Nail bed injuries, Nail, Children, Fingertip injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulty
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 22 May 2017 (actual)
- Primary completion
- 19 Jun 2020 (actual)
- Study completion
- 19 Jun 2020 (actual)
- First posted
- 6 Jan 2017 (estimated)
- 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.
Nail bed injuries in children, most frequently under 3 years-old, result in crush injuries. The frequency is around 34 percent of the children hand injuries (Claudet et al, 2007). The empirical reparation technique is the nail bed suture and the relocation of the nail plate. However, some authors think that suture the nail bed could increase the traumatism of the nail bed because of the needle, the crush by the clamps and by the stitches too tight (Langlois, Yam). An author has proposed, in a prospective, randomized clinical trial to treat the nail bed injuries with a glue: the 2-octylcyanoacrylate, without suture of the nail bed. Advantages of this technique, claimed by the author, was time saving, with an aesthetical result as same as the treatment with suture of the nail bed. A same study validated the technique in a paediatric population (Langlois et al., 2010). So, it seems that it is not necessary to suture the nail bed. But, in our practice, the investigators noted complications not mentioned in previous studies: hematomas causing pain, effusion and dislocation of the nail plate, with constrain the patient to consult in emergency. The 2-octylcyanoacrylate is difficult to use in nail bed injuries and is expensive. Our hypothesis is the simple relocation of the nail plate in nail bed injuries in paediatric population is enough to have good to excellent aesthetical results, with less complications and a lower cost, than the other techniques. The aim of this study is to assess the aesthetical results 3 months after simple relocation of the nail plate for nail bed injuries in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| relocation of nail plate | Experimental | Procedure: Simple relocation of the nail plate in nailbed injuries in paediatric populationthe simple relocation of the nail plate in nailbed injuries in paediatric population |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- age under 18 yo
- nail bed injuries and/or nail matrix
- nail plate > 30% of the surface comparing the opposite side
- one or more digits
- signature of the 2 parents
Key exclusion criteria (10 listed)
- loss of more than 30% of the surface of the nail bed
- Multiples lesions: nerve injury, tendon, fracture or luxation without indication of osteosynthesis, loss of skin with indication of a flap
- osteosynthesis of the distal phalanx
- injuries by bite
- previous pathology of the nail
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 |
|---|---|---|
| Simple relocation of the nail plate in nailbed injuries in paediatric populationAlso: Reparation of the nail bed injuries, Repositioning the nail bed without sutures, Relocation of the nailRepositioning the nail bed without sutures | Procedure or surgery | relocation of nail plate |
Primary outcome
Nail aesthetical results
Time frame: The evaluation is assessed at 6 months after the treatmen6
Evaluation with the Zook's scale at 6 months postoperative based on photographs of the injured finger compared with the finger on the opposite side. The evaluation will be done by five persons (surgeons, nurses, therapists….)
4 secondary outcomes
Complications rate at short term (before 15 days): haematoma, infection, dislocation of the nail plate,: hook nail
Time frame: at 15 days
The pain with an analogic scale for children over 7 years-old,
Time frame: at 6 months
Satisfaction rate at 6 months, compared with the contralateral finger, by the children (if possible) and by parents, on a scale to 0 (not satisfied) to 10 (very satisfied).
Time frame: at 6 months
Complications rate: haematoma, infection, dislocation of the nail plate,at medium term (between 15 days and 3 months): hook nail
Time frame: at 6 months
Results and safety
The study was stopped early (reason given: recruitment difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
Related trials for Nail Bed Injury
Recruiting
Nailbed Repair for Patients With Nailbed Injuries
Nail Bed Injury, Nail Laceration
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple relocation of the nail plate in nailbed injuries in paediatric population in people with Nail Bed Injury, run by University Hospital, Strasbourg, France at 1 site in France.
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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 was stopped early (reason given: recruitment difficulty). Results are not available in the source record.
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?
Nail aesthetical results (time frame: The evaluation is assessed at 6 months after the treatmen6). 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 28 Jul 2020.