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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04124133
Recruitment Status : Completed
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Laboratoires Genévrier

Brief Summary:

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.


Condition or disease Intervention/treatment
Second-degree Burn of Children Device: dressing with hyaluronic acid

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


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Study Type : Observational
Actual Enrollment : 92 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Retrospective Study Evaluating Efficacy and Safety of Ialuset Cream or Gauzepad in Second Degree Burns Use for Children
Actual Study Start Date : December 10, 2018
Actual Primary Completion Date : April 18, 2019
Actual Study Completion Date : April 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns


Intervention Details:
  • Device: dressing with hyaluronic acid
    Application of ialuset cream or gauzepad (hyaluronic acid)


Primary Outcome Measures :
  1. Patient rate with complete healing [ Time Frame: 21 days ]
    pourcentage of patient with 100% of reepithelilisation



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 15 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Children from 1month to 15 years with a second degree burn
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124133


Locations
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France
CHU Besançon
Besançon, France
Sponsors and Collaborators
Laboratoires Genévrier
Investigators
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Principal Investigator: Arnaud Fotso Kamdem CHU Besançon

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Responsible Party: Laboratoires Genévrier
ClinicalTrials.gov Identifier: NCT04124133     History of Changes
Other Study ID Numbers: CHILD study
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Burns
Wounds and Injuries
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents