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A2B-trial Antibioprophylaxis for excision-graft surgery in burn patient : a multicenter randomized double-bling study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514349-13-00
Acronym
APHP180605
Enrollment
506
Registered
2024-08-23
Start date
2020-10-11
Completion date
Unknown
Last updated
2025-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Excision-autograft surgery in burn patient

Brief summary

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

Detailed description

- 90 days mortality, - Skin raft lysis requiring a new autograft procedure, - Post-operative pulmonary infection, - Number of days of hospitalization until complete healing (> 95% total burn surface area), - Number of hospitalization days living without antibiotic therapy at D28 and D90, - Multiresistant bacteria (15) colonization of infection at D28 and D90

Interventions

DRUGPlacebo de Cefazoline / Piperaciline / Tazobactam
DRUGCEFAZOLIN
DRUGPIPERACILLINE TAZOBACTAM VIATRIS 4 g/0
DRUG5 g

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
- 90 days mortality, - Skin raft lysis requiring a new autograft procedure, - Post-operative pulmonary infection, - Number of days of hospitalization until complete healing (> 95% total burn surface area), - Number of hospitalization days living without antibiotic therapy at D28 and D90, - Multiresistant bacteria (15) colonization of infection at D28 and D90

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026