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The goal of this prospective, multicentre, double-blind, randomized clinical trial is to compare intermittent cefoxitin administration to loading bolus followed by continuous infusion for surgical antibiotic prophylaxis in colorectal surgery.
The main objective is to demonstrate the superiority of a loading dose of cefoxitin followed by continuous infusion over standard of care boluses in reducing SSI within 30 days after colorectal surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group (innovative administration scheme) | Experimental | Continuous infusion of cefoxitin + Intermittent placebo |
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| Control group (recommended administration scheme) | Active Comparator | Intermittent cefoxitin + Continuous infusion of placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loading bolus of cefoxitin | Drug | Cefoxitin [2g] before incision |
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| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection | Proportion of patients with any surgical site infection according to the CDC criteria | within 30 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthieu BOISSON, MD-PhD | Contact | +33549444635 | matthieu.boisson@chu-poitiers.fr | |
| Nadia TEIXEIRA | Contact | 0549444444 | nadia.teixeira@chu-poitiers.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Poitiers | Recruiting | Poitiers | Vienne | 86021 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39880423 | Derived | Saint-Genis Q, Birckener J, Gourdou V, Nicolle C, Garnier M, Schwindenhammer V, Hannezo C, Aveline C, Cinotti R, Puisney B, Garot M, Chevalier S, Aubert JS, Wodey M, Lasocki S, Lecoeur S, Lagarrigue CJ, Li A, Faucher M, Foucher Y, Frasca D, Boisson M. Multicentre, double-blind, randomised controlled clinical trial comparing intermittent cefoxitin administration versus loading bolus followed by continuous infusion for the prevention of surgical site infection in colorectal surgery: the PROPHYLOXITIN study protocol. BMJ Open. 2025 Jan 28;15(1):e088306. doi: 10.1136/bmjopen-2024-088306. |
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| Intermittent cefoxitin | Drug | Additional bolus of cefoxitin [1g] every 2 hours until the end of surgical closure |
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| Continuous infusion of placebo | Drug | Continuous infusion of placebo from the end of the loading bolus until the end of surgical closure |
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| Continuous infusion of cefoxitin | Drug | Continuous infusion of cefoxitin [0.5g/h] from the end of the loading bolus until the end of surgical closure |
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| Intermittent placebo | Drug | Additional bolus of placebo every 2 hours until the end of surgical closure |
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| CHU Angers | Recruiting | Angers | France |
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| Hopital privé Arras les Bonnettes | Recruiting | Arras | France |
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| CHU Caen | Recruiting | Caen | France |
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| CHU Clermont Ferrand | Recruiting | Clermont-Ferrand | France |
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| CHU Grenoble | Recruiting | Grenoble | France |
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| Centre Léon Bérard | Recruiting | Lyon | France |
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| Hospices Civils Lyon | Recruiting | Lyon | France |
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| Institut Paoli Calmettes | Recruiting | Marseille | France |
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| CHRU Nancy | Recruiting | Nancy | France |
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| CHU de Nantes | Recruiting | Nantes | France |
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| Hopital Européen Gorges Pompidou | Recruiting | Paris | France |
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| Clinique Mutualiste la Sagesse | Recruiting | Rennes | France |
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| Hôpital Privé Rennais Cesson Sevigné | Recruiting | Rennes | France |
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| CH St Brieuc | Recruiting | Saint-Brieuc | France |
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| CHU St Etienne | Recruiting | Saint-Etienne | France |
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| Hopitaux de Strasbourg | Recruiting | Strasbourg | France |
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| CHU Toulouse Rangueil | Recruiting | Toulouse | France |
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| CH Bretagne Atlantique vannes | Recruiting | Vannes | France |
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