Clinical trial NCT03013608: Children's Nail Bed Injuries : Study of the Efficacy of the Simple Relocation of Nail Plate
Official title: Children's Nail Bed Injuries : Study of the Efficacy of the Simple Relocation of Nail Plate
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nail Bed Injury
Keywords: Nail bed injury
Nail bed injuries
Nail
Children
Fingertip injury
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 7
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Nail aesthetical results
timeFrame: The evaluation is assessed at 6 months after the treatmen6
Secondary outcomes:
measure: Complications rate at short term (before 15 days): haematoma, infection, dislocation of the nail plate,: hook nail
timeFrame: at 15 days
measure: The pain with an analogic scale for children over 7 years-old,
timeFrame: at 6 months
measure: 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).
timeFrame: at 6 months
measure: Complications rate: haematoma, infection, dislocation of the nail plate,at medium term (between 15 days and 3 months): hook nail
timeFrame: at 6 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: CHU Strasbourg,
Study officials:
References: