Burns SurgeryPhase 3A2BNCT04292054
Antibioprophylaxis for Excision-graft Surgery in Burn Patient (A2B-TRIAL)
A Phase 3 study testing active intervention in people with Burns Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The indication of antibiotic prophylaxis in burn patients remains highly controversial and hasn't reached a consensus. The objective of antibiotic prophylaxis would be to reduce the risk of post-operative local and systemic infections. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Burns Surgery
- What is being tested?
- active intervention
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 506 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2020to 9 Jul 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years and less than 80 years old
- Burned patients requiring at least one excision-graft surgery
- Burn TBSA% between 5% and 40%
- Signed informed consent or inclusion under the emergency provisions of the law (article L1122-1-2 of the CSP)
Who cannot join
- Proven severe allergy to cephalosporin or piperacilline-tazobactam or any other antibacterial agent of the penicillin class
- History of severe allergic reaction to any other beta-lactam (eg cephalosporins, monobactams or carbapenems).
- Patient on antibiotic therapy at the time of surgery
- Pregnant or breast-feeding patient
- Patient not covered by the social security
- Patient transferred from another burn Unit
Show all 12Show fewer
- Patient participant in investigational competitive medicinal product study on the primary endpoint
- Patient with local or systemic signs of infection requiring systemic antimicrobial therapy
- Patient under guardianship
- Patient under curatorship
- known colonization of the burned area to be excised with tazocillin-resistant germ.
- obese patient with BMI > 50 kg/m²
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Saint Louis Hospital
Paris, 75010
François Depret, PhD, +33171207559, francois.depret@aphp.fr
About this study
Official title: "Antibioprophylaxis for Excision-graft Surgery in Burn Patient: a Multicenter Randomized Double-blind Study: A2B Trial"
The indication of antibiotic prophylaxis in burn patients remains highly controversial and hasn't reached a consensus. The objective of antibiotic prophylaxis would be to reduce the risk of post-operative local and systemic infections. Burn surgery is associated with a high risk of bacteremia and postoperative infections and sepsis. However, antibiotic prophylaxis exposes to the risk of selecting drug-resistant pathogens as well as adverse effects of antibiotics (i.e Clostridium difficile colitis).
Recommendations regarding perioperative prophylaxis using systemic antibiotics vary across sources. The lack of data precludes any international strong recommendations regarding the best strategy regarding antibiotic prophylaxis.
The goal of this project is therefore to determine whether peri-operative systemic antibiotics prophylaxis could reduce the incidence of post-operative infections in burn patients.
Read the detailed description
The intensive care unit investigator will verify the inclusion and non-inclusion criteria.
The following parameters will be collected at ICU/burn centers: Hemodynamic parameters; sepsis organ failure assessment (SOFA) score, Glasgow Coma scale; Medical history / comorbidities; Concomitant treatment; Burn wound bacterial colonization; Biological parameters.
The inclusion and randomization will be performed as late as possible before the first surgical procedure.
Randomization: Burn patients with deep burn between 5 to 40% TBSA requiring at least one excision surgery graft will be randomized to receive antibioprophylaxis (or placebo) 30 minutes before the incision with either first generation cephalosporin (cefazolin) (if absence of colonization to Pseudomonas aeruginosa); or piperacillin-tazobactam (if the burned area is colonized with Pseudomonas aeruginosa). We chose to target specifically Pseudomonas aeruginosa because it has been associated with significant morbidity and risk of graft lysis in burn patients.
No specific exams are required during the 7 days, 28 days and 90 days follow up visits.
The end of research visit is the 90-day follow-up visit. If the patient has been discharged from the hospital, the 90-day visit will consist of a telephone contact with the patient if he or she has been discharged home or with the medical team of the healthcare structure if the patient has been discharged to another structure.
- Conditions
- Burns Surgery
- Being tested
- active intervention, placebo intervention
- Keywords
- Antibioprophylaxis, sepsis, infection, graft lysis
- Medical subject headings
- Sepsis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active interventionDrug
Also called Cefazolin or piperacilline-tazobactam 4 g
The antibiotic prophylaxis will be cefazolin 2 g, or piperacilline-tazobactam 4 g, powder for solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe pump.
placebo interventionOther
Also called NaC 0,9%l
The control group will received, as placebo NaCl 0.9% solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe pump.
| Study group | Role | What they receive |
|---|---|---|
| active group | Active comparator | The antibiotic prophylaxis will be cefazolin 2 g powder for solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe pump, in case of absence of colonization to Pseudomonas aeruginosa prior to the surgical procedure.
The dose administer is 2g.
Antibiotic prophylaxis will be piperacilline-tazobactam 4 g powder for solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe driver in patients with burn wound colonized to Pseudomonas aeruginosa.
The dose administer is 4g. Receives: Drug: active intervention |
| Placebo group | Placebo comparator | The control group will received, as placebo NaCl 0.9% solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe pump. Receives: Other: placebo intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative infection defined as Post-operative sepsis and/or Surgical site infection, and/or Graft lysis requiring a new graft within 7 days after surgery.
Postoperative infection will be collected by the intensivists or infectious disease specialist consultant blinded to the interventional or control arm. Skin infection and skin graft lysis requiring a new graft procedure will be assess by a surgeon blinded of the arm of the study.
Measured: 7 days after surgery
Post-operative sepsis
Sepsis is defined as life-threatening organ dysfunction (defined by an increase of Sepsis related organ failure assessment [SOFA] score of 2 points or more) in response to infection. The minimum value is 0 and maximum value is 24. 0 meaning no organ dysfunction and 24 the maximum organ dysfunction.
Measured: 7 days after surgery
Surgical site infection
Surgical site (operated skin) infection with general signs is considered as a systemic infection originated from skin (Presence of a local or loco-regional inflammatory reaction; Unfavourable and unexpected local evolution; Lysis of grafts; Necrosis of fat located under the graft)
Measured: 7 days after surgery
Graft lysis needing a new graft procedure
Graft lysis is defined as a skin graft lysis in the 7 days post operative, and needing a new skin graft assessed be a surgeon blinded of the randomization group.
Measured: 7 days after surgery
Secondary outcomes (8)
Mortality
Any death occurring between randomization and D 90
Measured: At day 90
Skin graft lysis requiring a new graft procedure
Defined as a skin graft lysis in the 7 days post operative, and needing a new skin graft assessed be a surgeon blinded of the randomization group.
Measured: 7 days after surgery
Postoperative bacteremia
Positive blood culture .
Measured: within 7 days of surgery
Post-operative pulmonary infection
Imaging Test Evidence
Two or more serial chest imaging test results with at least one of the following:
New and persistent or Progressive and persistent
- Infiltrate
- Consolidation
- Cavitation Signs/Symptoms/Laboratory
For ANY PATIENT, at least one of the following:
- Fever (>38.0°C or >100.4°F)
- Leukopenia (≤4000 WBC/mm) or leukocytosis (>12,000 WBC/mm)
- For adults >70 years old, altered mental status with no other recognized cause
And at least two of the following:
- New onset of purulent sputum or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements
- New onset or worsening cough, or dyspnea, or tachypnea
- Rales or bronchial breath sounds
- Worsening gas exchange
Measured: 7 days after surgery
Post-operative surgical site infection
Skin infection with general signs is considered as a systemic infection originated from skin.
Measured: 7 days after surgery
Number of hospitalization days living without antibiotic therapy
It will be calculated as the number of survival days without antibiotic therapy respectively between randomization and day 28 and day 90.
Measured: at Day 28 and Day 90
Number of days of hospitalization until complete healing (> 95% total burn surface area)
It will be calculated by the number of days between ICU complete healing and ICU discharge.
Measured: at Day 28 and Day 90
Number of patients with a colonization with a multidrug resistant bacteria.
It will be defined as :
AmpC producer enterobacteriacae Extended spectrum beta lactamase enterobacteriacae Carbapenemase producer enterobacteriacae Meticillin resistant aureus staphylococcus Vancomycine resistant enterococcus Piperacillin-Tazobactam resistant bacteria Imipenem resistant Acinetobacter Baumanii. And it will be mesured from results of bacterial cultures and/or genotyping with antibiogramm resistance profile
Measured: at Day 28 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start11 Oct 2020
- Primary completion18 Apr 2026 (estimated)
- Study completion9 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burns SurgeryStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized controlled study with two arms (1:1) Arm 1 : With antibiotic prophylaxis strategy, (cefazolin) if absence of colonization to Pseudomonas aeruginosa; or (piperacilline-tazobactam) if the burn is colonized with Pseudomonas aeruginosa. Arm 2 : Without antibiotic prophylaxis strategy (placebo)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 506 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François DEPRET, MD, Principal investigator, Department of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292054
- Sponsor's protocol ID
- APHP180605
- Acronym
- A2B
- Status last verified
- Oct 2025
- First submitted
- 17 Feb 2020
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Depret F, Farny B, Jeanne M, Klouche K, Leclerc T, Nouette-Gaulain K, Pantet O, Remerand F, Roquilly A, Rousseau AF, Sztajnic S, Wiramus S, Vicaut E, Legrand M; A2B trial investigators. The A2B trial, antibiotic prophylaxis for excision-graft surgery in burn patients: a multicenter randomized double-blind study. Trials. 2020 Nov 25;21(1):973. doi: 10.1186/s13063-020-04894-y.
PubMed 33239101
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Antibioprophylaxis for Excision-graft Surgery in Burn Patient: a Multicenter Randomized Double-blind Study: A2B Trial"
- ClinicalTrials.gov ID
- NCT04292054
- Acronym / sponsor ID
- A2B / APHP180605
- Conditions
- Burns Surgery
- Keywords
- Antibioprophylaxis, sepsis, infection, graft lysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 506 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 11 Oct 2020 (actual)
- Primary completion
- 18 Apr 2026 (estimated)
- Study completion
- 9 Jul 2026 (estimated)
- First posted
- 2 Mar 2020 (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.
The indication of antibiotic prophylaxis in burn patients remains highly controversial and hasn't reached a consensus. The objective of antibiotic prophylaxis would be to reduce the risk of post-operative local and systemic infections. Burn surgery is associated with a high risk of bacteremia and postoperative infections and sepsis. However, antibiotic prophylaxis exposes to the risk of selecting drug-resistant pathogens as well as adverse effects of antibiotics (i.e Clostridium difficile colitis).
Recommendations regarding perioperative prophylaxis using systemic antibiotics vary across sources. The lack of data precludes any international strong recommendations regarding the best strategy regarding antibiotic prophylaxis.
The goal of this project is therefore to determine whether peri-operative systemic antibiotics prophylaxis could reduce the incidence of post-operative infections in burn patients.
Detailed description
The intensive care unit investigator will verify the inclusion and non-inclusion criteria.
The following parameters will be collected at ICU/burn centers: Hemodynamic parameters; sepsis organ failure assessment (SOFA) score, Glasgow Coma scale; Medical history / comorbidities; Concomitant treatment; Burn wound bacterial colonization; Biological parameters.
The inclusion and randomization will be performed as late as possible before the first surgical procedure.
Randomization: Burn patients with deep burn between 5 to 40% TBSA requiring at least one excision surgery graft will be randomized to receive antibioprophylaxis (or placebo) 30 minutes before the incision with either first generation cephalosporin (cefazolin) (if absence of colonization to Pseudomonas aeruginosa); or piperacillin-tazobactam (if the burned area is colonized with Pseudomonas aeruginosa). We chose to target specifically Pseudomonas aeruginosa because it has been associated with significant morbidity and risk of graft lysis in burn patients.
No specific exams are required during the 7 days, 28 days and 90 days follow up visits.
The end of research visit is the 90-day follow-up visit. If the patient has been discharged from the hospital, the 90-day visit will consist of a telephone contact with the patient if he or she has been discharged home or with the medical team of the healthcare structure if the patient has been discharged to another structure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blind, randomized controlled study with two arms (1:1) Arm 1 : With antibiotic prophylaxis strategy, (cefazolin) if absence of colonization to Pseudomonas aeruginosa; or (piperacilline-tazobactam) if the burn is colonized with Pseudomonas aeruginosa. Arm 2 : Without antibiotic prophylaxis strategy (placebo)
| Arm | Type | Receives |
|---|---|---|
| active group | Active comparator | Drug: active interventionThe antibiotic prophylaxis will be cefazolin 2 g powder for solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe pump, in case of absence of colonization to Pseudomonas aeruginosa prior to the surgical procedure. The dose administer is 2g. Antibiotic prophylaxis will be piperacilline-tazobactam 4 g powder for solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe driver in patients with burn wound colonized to Pseudomonas aeruginosa. The dose administer is 4g. |
| Placebo group | Placebo comparator | Other: placebo interventionThe control group will received, as placebo NaCl 0.9% solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe pump. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient over 18 years and less than 80 years old
- Burned patients requiring at least one excision-graft surgery
- Burn TBSA% between 5% and 40%
- Signed informed consent or inclusion under the emergency provisions of the law (article L1122-1-2 of the CSP)
Key exclusion criteria (12 listed)
- Proven severe allergy to cephalosporin or piperacilline-tazobactam or any other antibacterial agent of the penicillin class
- History of severe allergic reaction to any other beta-lactam (eg cephalosporins, monobactams or carbapenems).
- Patient on antibiotic therapy at the time of surgery
- Pregnant or breast-feeding patient
- Patient not covered by the social security
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 |
|---|---|---|
| active interventionAlso: Cefazolin or piperacilline-tazobactam 4 gThe antibiotic prophylaxis will be cefazolin 2 g, or piperacilline-tazobactam 4 g, powder for solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe pump. | Drug | active group |
| placebo interventionAlso: NaC 0,9%lThe control group will received, as placebo NaCl 0.9% solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe pump. | Other | Placebo group |
Primary outcome
Post-operative infection defined as Post-operative sepsis and/or Surgical site infection, and/or Graft lysis requiring a new graft within 7 days after surgery.
Time frame: 7 days after surgery
Postoperative infection will be collected by the intensivists or infectious disease specialist consultant blinded to the interventional or control arm. Skin infection and skin graft lysis requiring a new graft procedure will be assess by a surgeon blinded of the arm of the study.
Post-operative sepsis
Time frame: 7 days after surgery
Sepsis is defined as life-threatening organ dysfunction (defined by an increase of Sepsis related organ failure assessment [SOFA] score of 2 points or more) in response to infection. The minimum value is 0 and maximum value is 24. 0 meaning no organ dysfunction and 24 the maximum organ dysfunction.
Surgical site infection
Time frame: 7 days after surgery
Surgical site (operated skin) infection with general signs is considered as a systemic infection originated from skin (Presence of a local or loco-regional inflammatory reaction; Unfavourable and unexpected local evolution; Lysis of grafts; Necrosis of fat located under the graft)
Graft lysis needing a new graft procedure
Time frame: 7 days after surgery
Graft lysis is defined as a skin graft lysis in the 7 days post operative, and needing a new skin graft assessed be a surgeon blinded of the randomization group.
8 secondary outcomes
Mortality
Time frame: At day 90
Skin graft lysis requiring a new graft procedure
Time frame: 7 days after surgery
Postoperative bacteremia
Time frame: within 7 days of surgery
Post-operative pulmonary infection
Time frame: 7 days after surgery
Post-operative surgical site infection
Time frame: 7 days after surgery
Number of hospitalization days living without antibiotic therapy
Time frame: at Day 28 and Day 90
Number of days of hospitalization until complete healing (> 95% total burn surface area)
Time frame: at Day 28 and Day 90
Number of patients with a colonization with a multidrug resistant bacteria.
Time frame: at Day 28 and Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Derived from this study: PubMed 33239101Depret F, Farny B, Jeanne M, Klouche K, Leclerc T, Nouette-Gaulain K, Pantet O, Remerand F, Roquilly A, Rousseau AF, Sztajnic S, Wiramus S, Vicaut E, Legrand M; A2B trial investigators. The A2B trial, antibiotic prophylaxis for excision-graft surgery in burn patients: a multicenter randomized double-blind study. Trials. 2020 Nov 25;21(1):973. doi: 10.1186/s13063-020-04894-y.
- 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.
François DEPRET, MD principal investigator
Department of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing active intervention in people with Burns Surgery, 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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 24 Nov 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François DEPRET, MD (01 42 49 95 70 ext. 00 33, francois.depret@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative infection defined as Post-operative sepsis and/or Surgical site infection, and/or Graft lysis requiring a new graft within 7 days after surgery. (time frame: 7 days after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04292054, which also lists 1 linked publication.
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 24 Nov 2025.