Children's Nail Bed Injuries : Study of the Efficacy of the Simple Relocation of Nail Plate (Ongl'HUS)
Primary Purpose
Nail Bed Injury
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Simple relocation of the nail plate in nailbed injuries in paediatric population
Sponsored by
About this trial
This is an interventional treatment trial for Nail Bed Injury focused on measuring Nail bed injury, Nail bed injuries, Nail, Children, Fingertip injury
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
Sites / Locations
- CHU Strasbourg,
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
relocation of nail plate
Arm Description
the simple relocation of the nail plate in nailbed injuries in paediatric population
Outcomes
Primary Outcome Measures
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….)
Secondary Outcome Measures
Complications rate at short term (before 15 days): haematoma, infection, dislocation of the nail plate,: hook nail
The pain with an analogic scale for children over 7 years-old,
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)
Complications rate: haematoma, infection, dislocation of the nail plate,at medium term (between 15 days and 3 months): hook nail
Full Information
NCT ID
NCT03013608
First Posted
January 4, 2017
Last Updated
July 24, 2020
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT03013608
Brief Title
Children's Nail Bed Injuries : Study of the Efficacy of the Simple Relocation of Nail Plate
Acronym
Ongl'HUS
Official Title
Children's Nail Bed Injuries : Study of the Efficacy of the Simple Relocation of Nail Plate
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulty
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
June 19, 2020 (Actual)
Study Completion Date
June 19, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nail Bed Injury
Keywords
Nail bed injury, Nail bed injuries, Nail, Children, Fingertip injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
relocation of nail plate
Arm Type
Experimental
Arm Description
the simple relocation of the nail plate in nailbed injuries in paediatric population
Intervention Type
Procedure
Intervention Name(s)
Simple relocation of the nail plate in nailbed injuries in paediatric population
Other Intervention Name(s)
Reparation of the nail bed injuries, Repositioning the nail bed without sutures, Relocation of the nail
Intervention Description
Repositioning the nail bed without sutures
Primary Outcome Measure Information:
Title
Nail aesthetical results
Description
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….)
Time Frame
The evaluation is assessed at 6 months after the treatmen6
Secondary Outcome Measure Information:
Title
Complications rate at short term (before 15 days): haematoma, infection, dislocation of the nail plate,: hook nail
Time Frame
at 15 days
Title
The pain with an analogic scale for children over 7 years-old,
Time Frame
at 6 months
Title
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).
Description
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)
Time Frame
at 6 months
Title
Complications rate: haematoma, infection, dislocation of the nail plate,at medium term (between 15 days and 3 months): hook nail
Time Frame
at 6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU Strasbourg,
City
Strasbourg
ZIP/Postal Code
67000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Children's Nail Bed Injuries : Study of the Efficacy of the Simple Relocation of Nail Plate
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