Using antibiotics to prevent infections in burn surgery patients
"Antibioprophylaxis for Excision-graft Surgery in Burn Patient: a Multicenter Randomized Double-blind Study: A2B Trial"
This study tests if giving antibiotics before surgery can help prevent infections in burn patients who are having skin grafts.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 506 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04292054 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of antibiotic prophylaxis in reducing post-operative infections in burn patients undergoing excision-graft surgery. Patients with deep burns covering 5 to 40% of their total body surface area will be randomly assigned to receive either antibiotics or a placebo shortly before surgery. The study will monitor various health parameters, including the incidence of infections and the patient's overall recovery over a 90-day follow-up period. The trial seeks to address the ongoing debate regarding the use of antibiotics in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with deep burns requiring excision-graft surgery.
Not a fit: Patients with severe allergies to the study antibiotics or those currently on antibiotic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of infections and improve recovery outcomes for burn patients undergoing surgery.
How similar studies have performed: While the use of antibiotic prophylaxis in surgical settings has been explored, this specific approach in burn patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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: * 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 * 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
Where this trial is running
Paris
- Saint Louis Hospital — Paris, France (Recruiting)
Study contacts
- Principal investigator: François DEPRET, MD — Department of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital
- Study coordinator: François DEPRET, MD
- Email: francois.depret@aphp.fr
- Phone: 01 42 49 95 70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.