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The surgical site infection is one of the most important causes of postoperative morbidity. The appropriate antibiotic prophylaxis is one of the most effective ways to prevent surgical site infections. The recommendations of the French Society of Anesthesia Resuscitation on antibiotic prophylaxis in long surgeries are based on low documentation, including frequency and dosage of reinjection.
The main objective of the study is to describe the tissue and plasma pharmacokinetics of cefoxitin after repeated injections.
This is an open monocentric study (phase 4) including adults aged 18 to 80 years in need of major abdominal surgery whose foreseeable time exceeds 4 hours and justifying an antibiotic prophylaxis by cefoxitin.
They receive 2 g cefoxitin parenterally at least 30 minutes before the incision and then every 2 hours until closing.
The primary endpoints are:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cefoxitin | Drug | Parenteral administration of 2g of cefoxitin at least 30 minutes before incision and then every 2 hours until closing |
| Measure | Description | Time Frame |
|---|---|---|
| Total and free plasma of cefoxitin after repeated injections | 48 hours | |
| Free tissue concentration of cefoxitin every 20 minutes after the beginning of injections | 48 hours | |
| Concentration of cefoxitin in urine after every injection | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time when tissue concentration of cefoxitin is higher than the minimal inhibitory concentration of target organisms | 48 hours | |
| Concentrations of antibiotic in peritoneal fluid | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Poitiers | Poitiers | 86021 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31220258 | Derived | Boisson M, Torres BGS, Yani S, Couet W, Mimoz O, Dahyot-Fizelier C, Marchand S, Gregoire N. Reassessing the dosing of cefoxitin prophylaxis during major abdominal surgery: insights from microdialysis and population pharmacokinetic modelling. J Antimicrob Chemother. 2019 Jul 1;74(7):1975-1983. doi: 10.1093/jac/dkz139. |
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| ID | Term |
|---|---|
| D002440 | Cefoxitin |
| ID | Term |
|---|---|
| D002513 | Cephamycins |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
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| Clearance of distribution of cefoxitin | 48 hours |
| Clearance of elimination of cefoxitin | 48 hours |
| Cmax of Cefoxitin | 48 hours |
| Vd of distribution o cefoxitin | 48 hours |
| Area under the curve of plasma and tissue concentration of cefoxitin | 48 hours |
| Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |