- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02804607
Children Severe Traumatic Skin Lesions and Functional Outcome
August 2, 2018 updated by: Centre Hospitalier Universitaire, Amiens
Traumatic skin lesions require an adapted and early patient care management
Study Overview
Detailed Description
Traumatic skin lesions and in particular the burns which happen to growing children are complex and require an adapted and early patient care management.
A child presents physical, psychological, and physiological characteristics which involve a specific functional prognosis.
The aim of the study was to evaluate the functional outcome after a mid-term period from a severe skin traumatism occurring during childhood and which had required an initial graft.
Study Type
Observational
Enrollment (Actual)
51
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Amiens, France, 80054
- CHU Amiens
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
children who were hospitalized for an extensive and deep skin lesion on at least one joint, at CHU Amiens, from April 1999 to December 2014, in the Physical and Rehabilitation Pediatric activity center.
Description
Inclusion Criteria:
- children who were hospitalized for an extensive and deep skin lesion on at least one joint, at CHU Amiens, from April 1999 to December 2014, in the Physical and Rehabilitation Pediatric activity center.
And with a serious skin lesion:
- What the total dermal area is estimated to be less than 25%
- Taking at least one articulation
- Dont a part is at least 2nd degree deep or third degree
Exclusion Criteria:
- First degree burns or superficial second degree Burns resulting in death in the acute phase
- A history of pre-burn disorders affecting growth
- Escarres
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
skin lesion
severe skin traumatism occurring during childhood and which had required an initial graft.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
autonomy
Time Frame: 5 years
|
for daily life activities (questionnaire)
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
appearance of contractures
Time Frame: 5 years
|
consultation follow-up
|
5 years
|
|
limited joint mobility
Time Frame: 5 years
|
consultation follow-up
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Séverine FRITOT, PhD, CHU Amiens
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 18, 2016
Primary Completion (Actual)
February 8, 2016
Study Completion (Actual)
February 8, 2016
Study Registration Dates
First Submitted
June 15, 2016
First Submitted That Met QC Criteria
June 16, 2016
First Posted (Estimate)
June 17, 2016
Study Record Updates
Last Update Posted (Actual)
August 3, 2018
Last Update Submitted That Met QC Criteria
August 2, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PI2016_843_0019
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Burns
-
Fondation Ophtalmologique Adolphe de RothschildNot yet recruiting
-
American Scitech InternationalJohnson & JohnsonUnknownBurns | Electric BurnsUnited States
-
MediWound LtdUnknownBurns, Upper Extremity | Burns, Lower ExtremitySlovakia
-
Singapore General HospitalUnknownAcute Thermal BurnsSingapore
-
RenovaCare, IncActive, not recruitingBurns | Burns Second Degree | Burns Deep Second DegreeUnited States
-
Sun Yat-sen UniversityCompleted
-
Hennepin Healthcare Research InstituteNot yet recruiting
-
Buckinghamshire Healthcare NHS TrustNot yet recruitingBurns Multiple
-
Virginia Commonwealth UniversityWithdrawn
-
Riphah International UniversityActive, not recruiting
Clinical Trials on questionnaire
-
H. Lee Moffitt Cancer Center and Research InstituteSan Diego State University; University of Minnesota; University of ArizonaCompletedAnxiety | Psychological StressUnited States
-
Centre Hospitalier Universitaire de NiceCompletedGeneral Population | TDAH | Children Aged 5 to 18 YearsFrance
-
Stanford UniversityRecruitingAstigmatism | Nearsightedness | FarsightednessUnited States
-
University Medical Center GoettingenCompletedOrofacial Pain | Sleep ProblemsGermany
-
University of LiegeCompletedCritical Illness | Covid19 | Psychological Stress | FamilyBelgium
-
Imperial College Healthcare NHS TrustNot yet recruitingCervical Myelopathy
-
Children's Hospitals and Clinics of MinnesotaCompletedFirearm Injury | Firearm Safety | Firearm OwnershipUnited States
-
Imperial College LondonRoyal Marsden NHS Foundation Trust; University College London Hospitals; The... and other collaboratorsCompleted
-
Fondazione Policlinico Universitario Agostino Gemelli...Recruiting
-
Rabin Medical CenterCompleted