Children's Nail Bed Injuries : Study of the Efficacy of the Simple Relocation of Nail Plate (Ongl'HUS)

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 Overview

• Status: Terminated
• Conditions: Nail Bed Injury
• Intervention / Treatment: Procedure: Simple relocation of the nail plate in nailbed injuries in paediatric population

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67000
    • CHU Strasbourg,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: relocation of nail plate; 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; Repositioning the nail bed without sutures; Other Names: Reparation of the nail bed injuries; Repositioning the nail bed without sutures; Relocation of the nail

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2017
• Primary Completion (Actual): June 19, 2020
• Study Completion (Actual): June 19, 2020

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (Estimate): January 6, 2017

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Children; Nail bed injury; Nail bed injuries; Nail; Fingertip injury
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 6529

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No