Second-degree Burn of ChildrenNCT04124133
Evaluation of Efficacy and Safety of Ialuset Cream and Gauze in Second-degree Burns on Child
An observational study of Second-degree Burn of Children, run by Laboratoires Genévrier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 month to 15 years
- Conditions the study is for
- Second-degree Burn of Children
- What is being tested?
- dressing with hyaluronic acid
- Type of treatment
- Medical device
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2018to 18 Apr 2019
- 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 1 month to 15 years
- All sexes
- Child
Study population: Children from 1month to 15 years with a second degree burn
Who may be able to join
- 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
Who cannot join
- patient who refused data collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Second-degree Burn of Children
- Being tested
- dressing with hyaluronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dressing with hyaluronic acidDevice
Application of ialuset cream or gauzepad (hyaluronic acid)
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient rate with complete healing
pourcentage of patient with 100% of reepithelilisation
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start10 Dec 2018
- Primary completion18 Apr 2019
- Study completion18 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Second-degree Burn of ChildrenStudies of the same condition, open and under way.
- 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Genévrier
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arnaud Fotso Kamdem, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124133
- Sponsor's protocol ID
- CHILD study
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 11 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective Study Evaluating Efficacy and Safety of Ialuset Cream or Gauzepad in Second Degree Burns Use for Children
- ClinicalTrials.gov ID
- NCT04124133
- Acronym / sponsor ID
- CHILD study
- Conditions
- Second-degree Burn of Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Laboratoires GenévrierIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 18 Apr 2019 (actual)
- Study completion
- 18 Apr 2019 (actual)
- First posted
- 11 Oct 2019 (actual)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- Children from 1month to 15 years with a second degree burn
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- patient who refused data collection
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 |
|---|---|---|
| dressing with hyaluronic acidApplication of ialuset cream or gauzepad (hyaluronic acid) | Device | – |
Primary outcome
Patient rate with complete healing
Time frame: 21 days
pourcentage of patient with 100% of reepithelilisation
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 11 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Arnaud Fotso Kamdem principal investigator
CHU Besançon
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 Second-degree Burn of Children, run by Laboratoires Genévrier 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 6 inclusion and 1 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 11 Oct 2019. 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?
Patient rate with complete healing (time frame: 21 days). 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 11 Oct 2019.