NCT02804607

Brief Summary

Traumatic skin lesions require an adapted and early patient care management

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2016

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

21 days

First QC Date

June 15, 2016

Last Update Submit

August 2, 2018

Conditions

Burns

Keywords

burnchildgraftdevelopmentcomplicationsautonomy

Outcome Measures

Primary Outcomes (1)

  • autonomy

    for daily life activities (questionnaire)

    5 years

Secondary Outcomes (2)

  • appearance of contractures

    5 years

  • limited joint mobility

    5 years

Study Arms (1)

skin lesion

severe skin traumatism occurring during childhood and which had required an initial graft.

Other: questionnaire

Interventions

questionnaireOTHER
skin lesion

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • First degree burns or superficial second degree Burns resulting in death in the acute phase
  • A history of pre-burn disorders affecting growth
  • Escarres

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Burns

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Séverine FRITOT, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 17, 2016

Study Start

January 18, 2016

Primary Completion

February 8, 2016

Study Completion

February 8, 2016

Last Updated

August 3, 2018

Record last verified: 2018-08

Locations

FR(1)