Children's Nail Bed Injuries : Study of the Efficacy of the Simple Relocation of Nail Plate

Study Overview
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Brief Summary
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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.

Official Title
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Children's Nail Bed Injuries : Study of the Efficacy of the Simple Relocation of Nail Plate

Conditions
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Nail Bed Injury

Intervention / Treatment
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* Procedure: Simple relocation of the nail plate in nailbed injuries in paediatric population


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 no information possible pregnancy breastfeeding other inclusion in another study

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: relocation of nail plate<br>the simple relocation of the nail plate in nailbed injuries in paediatric population | Procedure: Simple relocation of the nail plate in nailbed injuries in paediatric population<br>* Repositioning the nail bed without sutures<br>* Other names: Relocation of the nail;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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….) | The evaluation is assessed at 6 months after the treatmen6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications rate at short term (before 15 days): haematoma, infection, dislocation of the nail plate,: hook nail |  | at 15 days | 
| The pain with an analogic scale for children over 7 years-old, |  | 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) | at 6 months | 
| Complications rate: haematoma, infection, dislocation of the nail plate,at medium term (between 15 days and 3 months): hook nail |  | at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nail bed injury, Nail bed injuries, Nail, Children, Fingertip injury