Evaluation of Efficacy and Safety of Ialuset Cream and Gauze in Second-degree Burns on Child

October 10, 2019 updated by: Laboratoires Genévrier

Observational Retrospective Study Evaluating Efficacy and Safety of Ialuset Cream or Gauzepad in Second Degree Burns Use for Children

Observational retrospective monocentric study occured in the univeristy hospital center of Bensançon the department of pediatric surgery.

Data of patients treated in the hospital between January 2016 and January 2019 have been collected.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Coordinator investigator have put in place a protocol care for children with second degree burns since 2016.

It consists in detersion and cleaning of wound, application of ialuset cream and gauzepad (hyaluronic acid) during 21 days. After 21 days if patients are not healed, physician consider to perform grafting

Study Type

Observational

Enrollment (Actual)

92

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

  • France
      • Besançon, France
        • CHU Besançon

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

3 years to 11 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children from 1month to 15 years with a second degree burn

Description

Inclusion Criteria:

  • second-degree burns
  • less than 20% of the body surface
  • less than 15 years old
  • treated within 24 hours
  • 1st line of treatment with ialuset
  • treated at the center between 2016 and 2019

Exclusion Criteria:

  • patient who refused data collection

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient rate with complete healing
Time Frame: 21 days
pourcentage of patient with 100% of reepithelilisation
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Genévrier

Investigators

  • Principal Investigator: Arnaud Fotso Kamdem, CHU Besançon

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)

December 10, 2018

Primary Completion (Actual)

April 18, 2019

Study Completion (Actual)

April 18, 2019

Study Registration Dates

First Submitted

October 10, 2019

First Submitted That Met QC Criteria

October 10, 2019

First Posted (Actual)

October 11, 2019

Study Record Updates

Last Update Posted (Actual)

October 11, 2019

Last Update Submitted That Met QC Criteria

October 10, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHILD study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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