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

Second-degree Burn of Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04124133
• Other study ID #: CHILD study
• Status: Completed
• Start date: December 10, 2018
• Est. completion date: April 18, 2019

Study information

• Verified date: October 2019
• Source: Laboratoires Genévrier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 18, 2019
• Est. primary completion date: April 18, 2019
• Gender: All
• Age group: 1 Month to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Second-degree Burn of Children

Intervention

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

Locations

Country	Name	City	State
France	CHU Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Genévrier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient rate with complete healing	pourcentage of patient with 100% of reepithelilisation	21 days