BurnsNCT02804607
Children Severe Traumatic Skin Lesions and Functional Outcome
An observational study of Burns, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Traumatic skin lesions require an adapted and early patient care management Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Burns
- What is being tested?
- questionnaire
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2016to 8 Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- First degree burns or superficial second degree Burns resulting in death in the acute phase
- A history of pre-burn disorders affecting growth
- Escarres
Trial locations and contacts
1 site in 1 country.
About this study
Traumatic skin lesions require an adapted and early patient care management
Read the 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.
- Conditions
- Burns
- Being tested
- questionnaire
- Keywords
- burn, child, graft, development, complications, autonomy
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| skin lesion | severe skin traumatism occurring during childhood and which had required an initial graft. Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
autonomy
for daily life activities (questionnaire)
Measured: 5 years
Secondary outcomes (2)
appearance of contractures
consultation follow-up
Measured: 5 years
limited joint mobility
consultation follow-up
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start18 Jan 2016
- Primary completion8 Feb 2016
- Study completion8 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Séverine FRITOT, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804607
- Sponsor's protocol ID
- PI2016_843_0019
- Status last verified
- Aug 2018
- First submitted
- 15 Jun 2016
- Last updated
- 3 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children Severe Traumatic Skin Lesions and Functional Outcome
- ClinicalTrials.gov ID
- NCT02804607
- Acronym / sponsor ID
- PI2016_843_0019
- Conditions
- Burns
- Keywords
- burn, child, graft, development, complications, autonomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 18 Jan 2016 (actual)
- Primary completion
- 8 Feb 2016 (actual)
- Study completion
- 8 Feb 2016 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Traumatic skin lesions require an adapted and early patient care management
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| skin lesion | – | Other: questionnairesevere skin traumatism occurring during childhood and which had required an initial graft. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (3 listed)
- First degree burns or superficial second degree Burns resulting in death in the acute phase
- A history of pre-burn disorders affecting growth
- Escarres
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire | Other | skin lesion |
Primary outcome
autonomy
Time frame: 5 years
for daily life activities (questionnaire)
2 secondary outcomes
appearance of contractures
Time frame: 5 years
limited joint mobility
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Séverine FRITOT, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
autonomy (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.