BurnsEARLYBURNNCT02940171
Timing of Surgery And Outcome in Burn Patients ( EARLYBURN )
An observational study of Burns, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The prognostic of burn patients has improved over the last decades. Early excision of full thickness burns is thought to be one of the key factors which have led to prognostic improvement. Best timing for burn excision remain uncertain, however. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Early Excision of full thickness burn and Late Excision of full thickness burn
- Type of treatment
- Surgery or procedure
- How many people
- 470 participants
- Where
- 1 siteFrance
- Study dates
- 25 Dec 2016to 11 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with extensive skin burns, defined as greater than 20% of the total body surface
Who may be able to join
- Age >18 years
- Admission to a burn unit within 72 hours from a burn injury
- Total burned surface area (TBSA)>20%(2nd degree or 3rd degree) for any type of burn
- Patient covered by the social security
- Non-opposition to participate to the study and to the constitution of the biological collection
Who cannot join
- Decline to participate
- Decision not to resuscitate order before surgery
- Pregnant or breastfeeding patiente
- Decision to limit therapies in the first 24 hours
- Patient not resident in France
- Patient deprived of liberty
Trial locations and contacts
1 site in 1 country.
France1 site
Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital, University Paris Diderot
Paris, 75010
About this study
Official title: Impact of Timing of Surgery on Outcome of Severely Ill Burn Patients
The prognostic of burn patients has improved over the last decades. Early excision of full thickness burns is thought to be one of the key factors which have led to prognostic improvement. Best timing for burn excision remain uncertain, however. In this multicenter observational study, we aim at exploring the impact of timing of surgery on outcome in severely ill burn patients using a propensity analysis.
Read the detailed description
The first aim of the study is to explore the impact of timing of the first surgery on outcome of severely ill burn patients. Because a randomization would not be feasible in this setting, we will use a propensity analysis in matching patients receiving early surgery and those receiving late surgery. Secondary aims are to evaluate the impact of the timing of surgery on morbidity (organs failure, infections, sepsis) but also to assess the diagnostic and prognostic value of plasma and urine biomarkers in severely ill burn patients
- Conditions
- Burns
- Being tested
- Early Excision of full thickness burn, Late Excision of full thickness burn
- Keywords
- burns, critically ill, surgery outcome, mortality
- Medical subject headings
- Burns, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Excision of full thickness burnProcedure or surgery
Also called Early
first excision surgery of full -thickness burn performed within 48 hours from burn injury
Late Excision of full thickness burnProcedure or surgery
Also called Late
first excision surgery of full -thickness burn performed after 48 hours from burn injury
| Study group | Role | What they receive |
|---|---|---|
| Early surgery | Early Excision of full thickness burn First excision surgery of full -thickness burn performed within 48 hours from burn injury Receives: Procedure: Early Excision of full thickness burn | |
| Late surgery | Late Excision of full thickness burn First excision surgery of full -thickness burn performed after 48 hours from burn injury Receives: Procedure: Late Excision of full thickness burn |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 90 days
Secondary outcomes (8)
Organ failure
Measured: 28 and 60 days
Recovery from acute kidney
Measured: Until 28 and 60 days from burn injury
Median Sequential Organ Failure Assessment score (SOFA score) during first 28 days
Median Sequential Organ Failure Assessment score (SOFA score) during first 28
Measured: First 28 days
Nosocomial infections (numbers) during first 60 days
Nosocomial infections (numbers) during first 60 days
Measured: First 60 days
Nosocomial sepsis during first 60 days
Nosocomial sepsis during first 60 days
Measured: First 60 days
Length of stay in the ICU
Length of stay in the ICU
Measured: One year
analog scale of quality of life
Functional sequel at one year, the patient will assesassess his overall quality of life since his accident Scale 1 to 10, with 1: poor, 10: good
Measured: One year
One year mortality
One year mortality
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study start25 Dec 2016
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Why it stopped: Enrollment was stopped early due to heavy workload at burn care centers and the impact of the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu Dr Legrand, MD, PhD, Principal investigator, Saint-Louis Hospital, Paris, FranceMourad BENYAMINA, MD, PH, Principal investigator, Saint-Louis Hospital, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940171
- Sponsor's protocol ID
- NI 14029
- Acronym
- EARLYBURN
- Status last verified
- May 2026
- First submitted
- 17 Oct 2016
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Timing of Surgery on Outcome of Severely Ill Burn Patients
- ClinicalTrials.gov ID
- NCT02940171
- Acronym / sponsor ID
- EARLYBURN / NI 14029
- Conditions
- Burns
- Keywords
- burns, critically ill, surgery outcome, mortality
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment was stopped early due to heavy workload at burn care centers and the impact of the COVID-19 pandemic.
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Dec 2016 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 20 Oct 2016 (estimated)
- 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.
The prognostic of burn patients has improved over the last decades. Early excision of full thickness burns is thought to be one of the key factors which have led to prognostic improvement. Best timing for burn excision remain uncertain, however. In this multicenter observational study, we aim at exploring the impact of timing of surgery on outcome in severely ill burn patients using a propensity analysis.
Detailed description
The first aim of the study is to explore the impact of timing of the first surgery on outcome of severely ill burn patients. Because a randomization would not be feasible in this setting, we will use a propensity analysis in matching patients receiving early surgery and those receiving late surgery. Secondary aims are to evaluate the impact of the timing of surgery on morbidity (organs failure, infections, sepsis) but also to assess the diagnostic and prognostic value of plasma and urine biomarkers in severely ill burn patients
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early surgery | – | Procedure: Early Excision of full thickness burnEarly Excision of full thickness burn First excision surgery of full -thickness burn performed within 48 hours from burn injury |
| Late surgery | – | Procedure: Late Excision of full thickness burnLate Excision of full thickness burn First excision surgery of full -thickness burn performed after 48 hours from burn injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with extensive skin burns, defined as greater than 20% of the total body surface
Key inclusion criteria (5 listed)
- Age >18 years
- Admission to a burn unit within 72 hours from a burn injury
- Total burned surface area (TBSA)>20%(2nd degree or 3rd degree) for any type of burn
- Patient covered by the social security
- Non-opposition to participate to the study and to the constitution of the biological collection
Key exclusion criteria (6 listed)
- Decline to participate
- Decision not to resuscitate order before surgery
- Pregnant or breastfeeding patiente
- Decision to limit therapies in the first 24 hours
- Patient not resident in France
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 |
|---|---|---|
| Early Excision of full thickness burnAlso: Earlyfirst excision surgery of full -thickness burn performed within 48 hours from burn injury | Procedure or surgery | Early surgery |
| Late Excision of full thickness burnAlso: Latefirst excision surgery of full -thickness burn performed after 48 hours from burn injury | Procedure or surgery | Late surgery |
Primary outcome
mortality
Time frame: 90 days
8 secondary outcomes
Organ failure
Time frame: 28 and 60 days
Recovery from acute kidney
Time frame: Until 28 and 60 days from burn injury
Median Sequential Organ Failure Assessment score (SOFA score) during first 28 days
Time frame: First 28 days
Nosocomial infections (numbers) during first 60 days
Time frame: First 60 days
Nosocomial sepsis during first 60 days
Time frame: First 60 days
Length of stay in the ICU
Time frame: One year
analog scale of quality of life
Time frame: One year
One year mortality
Time frame: One year
Results and safety
The study was stopped early (reason given: Enrollment was stopped early due to heavy workload at burn care centers and the impact of the COVID-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- 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.
Matthieu Dr Legrand, MD, PhD principal investigator
Saint-Louis Hospital, Paris, France
Mourad BENYAMINA, MD, PH principal investigator
Saint-Louis Hospital, Paris, France
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 Burns, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 14 May 2026. 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 was stopped early (reason given: Enrollment was stopped early due to heavy workload at burn care centers and the impact of the COVID-19 pandemic.). Results are not available in the source record.
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?
mortality (time frame: 90 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 14 May 2026.