PIPERACILLIN SODIUM; TAZOBACTAM SODIUM for Burn injury requiring excision and autograft surgery

Inclusion criteria

• {"criterion_text":"- Major patient over 18 years"}
• {"criterion_text":"- Burned patients requiring at least one excision-graft surgery"}
• {"criterion_text":"- burn TBSA between 5 and 40%"}
• {"criterion_text":"- Signed informed consent or inclusion under the emergency provisions of the law (article L1122-1-2 of the CSP)"}

Exclusion criteria

• {"criterion_text":"- Proven severe allergy to cephalosporin or piperacilline-tazobactam or any other antibacterial agent of the penicillin class"}
• {"criterion_text":"- known colonization of the burned area to be excised with tazocillin-resistant germ."}
• {"criterion_text":"- obese patient with BMI > 50 kg/m²"}
• {"criterion_text":"- History of severe allergic reaction to any other beta-lactam (eg cephalosporins, monobactams or carbapenems)."}
• {"criterion_text":"- Patient on antibiotic therapy at the time of surgery"}
• {"criterion_text":"- Pregnant or breast-feeding patient"}
• {"criterion_text":"- Patient not covered by the social security"}
• {"criterion_text":"- Patient transferred from another burn Unit"}
• {"criterion_text":"- Patient participating in investigational competitive medicinal product study on the primary endpoint"}
• {"criterion_text":"- Patient with local or systemic signs of infection requiring systemic antimicrobial therapy"}
• {"criterion_text":"- Patient under guardianship or curatorship"}

Primary endpoints

• {"endpoint_text":"- Post-operative infection defined as Post-operative sepsis and/or surgical site infection, and/or autograft lysis requiring a new autograft within 7 days after surgery","definition_or_measurement_approach":"Defined as post-operative sepsis and/or surgical site infection and/or autograft lysis requiring a new autograft within 7 days after surgery (measured within 7 days postoperatively)."}

Secondary endpoints

• {"endpoint_text":"- 90 days mortality","definition_or_measurement_approach":"All-cause mortality assessed at 90 days post-procedure."}
• {"endpoint_text":"- Skin raft lysis requiring a new autograft procedure","definition_or_measurement_approach":"Occurrence of autograft (skin graft) lysis requiring a repeat autograft procedure."}
• {"endpoint_text":"- Post-operative pulmonary infection","definition_or_measurement_approach":"Post-operative pulmonary infection assessed after surgery (specific diagnostic criteria not detailed in the record)."}
• {"endpoint_text":"- Number of days of hospitalization until complete healing (> 95% total burn surface area)","definition_or_measurement_approach":"Number of days from surgery until complete healing defined as >95% of total burn surface area healed."}
• {"endpoint_text":"- Number of hospitalization days living without antibiotic therapy at D28 and D90","definition_or_measurement_approach":"Number of hospitalization days off antibiotic therapy measured at Day 28 and Day 90."}
• {"endpoint_text":"- Multiresistant bacteria (15) colonization of infection at D28 and D90","definition_or_measurement_approach":"Colonization/infection by multiresistant bacteria assessed at Day 28 and Day 90."}

Methods

• Recruitment through participating hospital burn and intensive care units at the listed multicenter hospital sites in France (site list in trial geography). No other recruitment channels specified in the record.

France

Earliest CTIS Part Ii Submission Date

14-08-2024

Latest Decision Or Authorization Date

02-04-2026

Processing Time Days

596

Number Of Sites

10

Number Of Participants

506

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France