Antibioprophylaxis for Excision-graft Surgery in Burn Patient (A2B-TRIAL)
Recruiting
Phase 3
Interventional Study
Burns Surgery
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 99
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 506 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Other
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About This 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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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)
Exclusion Criteria:…
Contacts