NCT03013608

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

May 22, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2020

Completed
Last Updated

July 28, 2020

Status Verified

August 1, 2019

Enrollment Period

3.1 years

First QC Date

January 4, 2017

Last Update Submit

July 24, 2020

Conditions

Nail Bed Injury

Keywords

Nail bed injuryNail bed injuriesNailChildrenFingertip injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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).

    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

Study Arms (1)

relocation of nail plate

EXPERIMENTAL

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

Interventions

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

Repositioning the nail bed without sutures

Also known as: Reparation of the nail bed injuries, Repositioning the nail bed without sutures, Relocation of the nail
relocation of nail plate

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Strasbourg,

Strasbourg, 67000, France

Location

MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 6, 2017

Study Start

May 22, 2017

Primary Completion

June 19, 2020

Study Completion

June 19, 2020

Last Updated

July 28, 2020

Record last verified: 2019-08

Locations

FR(1)