Intermittent Cefoxitin Administration Versus Loading Bolus Followed by Continuous Infusion for the Prevention of Surgical Site Infection in Colorectal Surgery
NCT ID: NCT05755789
Last Updated: 2024-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
2000 participants
INTERVENTIONAL
2023-06-22
2025-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Intervention group (innovative administration scheme)
Continuous infusion of cefoxitin + Intermittent placebo
Loading bolus of cefoxitin
Cefoxitin \[2g\] before incision
Continuous infusion of cefoxitin
Continuous infusion of cefoxitin \[0.5g/h\] from the end of the loading bolus until the end of surgical closure
Intermittent placebo
Additional bolus of placebo every 2 hours until the end of surgical closure
Control group (recommended administration scheme)
Intermittent cefoxitin + Continuous infusion of placebo
Loading bolus of cefoxitin
Cefoxitin \[2g\] before incision
Intermittent cefoxitin
Additional bolus of cefoxitin \[1g\] every 2 hours until the end of surgical closure
Continuous infusion of placebo
Continuous infusion of placebo from the end of the loading bolus until the end of surgical closure
Interventions
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Loading bolus of cefoxitin
Cefoxitin \[2g\] before incision
Intermittent cefoxitin
Additional bolus of cefoxitin \[1g\] every 2 hours until the end of surgical closure
Continuous infusion of placebo
Continuous infusion of placebo from the end of the loading bolus until the end of surgical closure
Continuous infusion of cefoxitin
Continuous infusion of cefoxitin \[0.5g/h\] from the end of the loading bolus until the end of surgical closure
Intermittent placebo
Additional bolus of placebo every 2 hours until the end of surgical closure
Eligibility Criteria
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Inclusion Criteria
* Undergoing colorectal surgery (predictable duration \> 90 min)
Exclusion Criteria
* Patients with extreme severe obesity (defined by a body mass index greater than 50 kg/m2)
* Patients with severe renal insufficiency (clearance creatinine \< 30ml/min)
* Active bacterial infection at the time of surgery or recent antimicrobial therapy (up to 2 weeks before surgery) except for oral surgical antibiotic prophylaxis
18 Years
ALL
No
Sponsors
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Poitiers University Hospital
OTHER
Responsible Party
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Locations
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Centre Hospitalier de Poitiers
Poitiers, Vienne, France
CHU Angers
Angers, , France
Hopital privé Arras les Bonnettes
Arras, , France
CHU Caen
Caen, , France
CHU Clermont Ferrand
Clermont-Ferrand, , France
CHU Grenoble
Grenoble, , France
Centre Léon Bérard
Lyon, , France
Hospices Civils Lyon
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
CHRU Nancy
Nancy, , France
CHU de Nantes
Nantes, , France
Hopital Européen Gorges Pompidou
Paris, , France
Clinique Mutualiste la Sagesse
Rennes, , France
Hôpital Privé Rennais Cesson Sevigné
Rennes, , France
CH St Brieuc
Saint-Brieuc, , France
CHU St Etienne
Saint-Etienne, , France
Hopitaux de Strasbourg
Strasbourg, , France
CHU Toulouse Rangueil
Toulouse, , France
CH Bretagne Atlantique vannes
Vannes, , France
Countries
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Central Contacts
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Facility Contacts
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Sigismond Lasocki, Pr
Role: primary
Matthias GAROT, Dr
Role: primary
Claire NICOLLE, Dr
Role: primary
Marc GARNIER, Dr
Role: primary
Victor Schwindenhammer, Dr
Role: primary
Cécile HANNEZO, Dr
Role: primary
Anne LI, Dr
Role: primary
Marion FAUCHER, Dr
Role: primary
Julien BIRCKENER, Dr
Role: primary
Raphael CINOTTI, Pr
Role: primary
Jean Sebastien AUBERT, Pr
Role: primary
Stéphanie CHEVALIER, Dr
Role: primary
Christophe AVELINE, Dr
Role: primary
Sylvain LECOEUR, Dr
Role: primary
Maxime WODEY, Dr
Role: primary
Charles LAGARRIGUE, Dr
Role: primary
Guillaume PORTA BONETE, Dr
Role: primary
Benjamin PUISNEY, Dr
Role: primary
References
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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.
Other Identifiers
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PROPHYLOXITIN
Identifier Type: -
Identifier Source: org_study_id
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