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

NCT ID: NCT03013608

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-22
• Study Completion Date: 2020-06-19

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.

Conditions

Nail Bed Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

relocation of nail plate

the simple relocation of the nail plate in nailbed injuries in paediatric population

Group Type: EXPERIMENTAL

Simple relocation of the nail plate in nailbed injuries in paediatric population

Intervention Type: PROCEDURE

Repositioning the nail bed without sutures

Interventions

Simple relocation of the nail plate in nailbed injuries in paediatric population

Repositioning the nail bed without sutures

Intervention Type: PROCEDURE

Other Intervention Names

Reparation of the nail bed injuries; Repositioning the nail bed without sutures; Relocation of the nail

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Strasbourg,

Strasbourg, , France

Countries

France

Other Identifiers

6529

Identifier Type: -

Identifier Source: org_study_id